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1. Hill DA, Hill SR: Counseling patients about hormone therapy and alternatives for menopausal symptoms. Am Fam Physician; 2010 Oct 1;82(7):801-7
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Counseling patients about hormone therapy and alternatives for menopausal symptoms.
  • The results of recent large clinical trials have led physicians and patients to question the safety of menopausal hormone therapy.
  • In the past, physicians prescribed hormone therapy in an attempt to improve overall health and prevent cardiac disease.
  • Hormone therapy appears to increase the risk of breast cancer when used for more than three to five years; therefore, regulatory agencies now advise that physicians prescribe it only to treat menopausal symptoms such as hot flashes and vaginal atrophy, with the smallest effective dosage and for the shortest possible duration.
  • Although estrogen is the most effective treatment for hot flashes, alternatives such as venlafaxine and gabapentin are effective for some patients.
  • In contrast to systemic estrogen therapy, topical estrogen therapy for vulvovaginal atrophy is more appealing for certain patients because it does not require the addition of a progestogen for endometrial protection.
  • Some have advocated selective estrogen reuptake modulators as alternatives to hormone therapy for the prevention of menopausal osteoporosis.
  • The decision to use either therapy depends on clinical presentation and a thorough evaluation of the risks and benefits, because both have potential detrimental health effects and both are linked to an increased risk of venous thromboembolism.
  • [MeSH-major] Breast Neoplasms / chemically induced. Estrogen Replacement Therapy / adverse effects. Hot Flashes / drug therapy. Osteoporosis, Postmenopausal / chemically induced. Selective Estrogen Receptor Modulators / therapeutic use
  • [MeSH-minor] Administration, Intravaginal. Aged. Bone Density Conservation Agents / therapeutic use. Cardiovascular Diseases / chemically induced. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Humans. Middle Aged. Plant Preparations / therapeutic use. Risk Factors

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  • [CommentIn] Am Fam Physician. 2011 Aug 15;84(4):354; author reply 354-5 [21842780.001]
  • (PMID = 20879703.001).
  • [ISSN] 1532-0650
  • [Journal-full-title] American family physician
  • [ISO-abbreviation] Am Fam Physician
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Bone Density Conservation Agents; 0 / Plant Preparations; 0 / Selective Estrogen Receptor Modulators
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2. Frank JE, Mistretta P, Will J: Diagnosis and treatment of female sexual dysfunction. Am Fam Physician; 2008 Mar 1;77(5):635-42
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Diagnosis and treatment of female sexual dysfunction.
  • Although laboratory evaluation is rarely helpful in guiding diagnosis or treatment, it may be indicated in women with abnormal physical examination findings or suspected comorbidities.
  • The PLISSIT (Permission, Limited Information, Specific Suggestions, Intensive Therapy) or ALLOW (Ask, Legitimize, Limitations, Open up, Work together) method can be used to facilitate discussions about sexual concerns and initiation of treatment.
  • Developments in the treatment of male erectile dysfunction have led to investigation of pharmacotherapy for the treatment of female sexual dysfunction.
  • Although sexual therapy and education (e.g., cognitive behavior therapy, individual and couple therapy, physiotherapy) form the basis of treatment, there is limited research demonstrating the benefit of hormonal and nonhormonal drugs.
  • Estrogen improves dyspareunia associated with vulvovaginal atrophy in postmenopausal women.
  • [MeSH-major] Hormone Replacement Therapy / methods. Sexual Dysfunction, Physiological / diagnosis. Sexual Dysfunction, Physiological / drug therapy. Sexual Dysfunctions, Psychological / diagnosis. Sexual Dysfunctions, Psychological / drug therapy
  • [MeSH-minor] Diagnosis, Differential. Female. Humans. Practice Guidelines as Topic. Treatment Outcome


3. Shulman LP: Transdermal hormone therapy and bone health. Clin Interv Aging; 2008;3(1):51-4
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  • [Title] Transdermal hormone therapy and bone health.
  • The clinical aftermath of the reporting of the initial findings of the Women's Health Initiative (WHI) in 2002 was a profound reduction in the use of hormone therapies by menopausal women.
  • This reduction led to a well documented increase in vasomotor symptoms and vaginal atrophy among those women who discontinued their hormone regimens.
  • Although the use ofnon-hormonal drugs such as bisphosphonates has been shown to reduce the risk of fracture in women with osteoporosis, bisphosphonates have not been shown to reduce the risk of fracture in non-osteoporotic women.
  • As non-oral hormone therapies have been shown to be as effective in treating vasomotor symptoms and vulvovaginal atrophy and to have a different (and perhaps more beneficial) physiological effect than oral regimens, it behooves us to assess the impact of non-oral hormone regimens on bone mineral density and fracture risk.
  • [MeSH-major] Bone Density / drug effects. Estrogen Replacement Therapy. Osteoporosis, Postmenopausal / prevention & control

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  • (PMID = 18488878.001).
  • [ISSN] 1176-9092
  • [Journal-full-title] Clinical interventions in aging
  • [ISO-abbreviation] Clin Interv Aging
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Number-of-references] 18
  • [Other-IDs] NLM/ PMC2544369
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4. Ibe C, Simon JA: Vulvovaginal atrophy: current and future therapies (CME). J Sex Med; 2010 Mar;7(3):1042-50; quiz 1051
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Vulvovaginal atrophy: current and future therapies (CME).
  • INTRODUCTION: Vulvovaginal atrophy results from estrogen deficiency and affects a large number of postmenopausal women.
  • AIM: The purpose of this review is to evaluate the efficacy, safety and acceptability of current treatment methods for vulvovaginal atrophy, as well as highlight evolving new treatment methods.
  • Method. We conducted a review of the literature concerning treatment of vulvovaginal atrophy.
  • Fears sparked by the Women's Health Initiative, as well as recommendations by the FDA, have generated interest in the development of new treatment methods.
  • The use of estrogen agonists/antagonists and intravaginal dehydroepiandrosterone (DHEA) have both been shown to positively affect vaginal atrophy symptoms without inducing endometrial proliferation.
  • CONCLUSION: Potential new treatment methods show promise to provide efficacy in treatment while avoiding unwanted side effects.
  • Further research is needed to establish optimal treatment formulations.
  • [MeSH-major] Drug Therapy / trends. Estrogens / therapeutic use. Vulvovaginitis / drug therapy. Vulvovaginitis / epidemiology
  • [MeSH-minor] Adjuvants, Immunologic / therapeutic use. Aged. Atrophy / drug therapy. Atrophy / epidemiology. Atrophy / pathology. Dehydroepiandrosterone / therapeutic use. Drug Administration Schedule. Dyspareunia / epidemiology. Dyspareunia / prevention & control. Female. Female Urogenital Diseases / drug therapy. Female Urogenital Diseases / epidemiology. Forecasting. Humans. Middle Aged. Postmenopause

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  • (PMID = 20500443.001).
  • [ISSN] 1743-6109
  • [Journal-full-title] The journal of sexual medicine
  • [ISO-abbreviation] J Sex Med
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Estrogens; 459AG36T1B / Dehydroepiandrosterone
  • [Number-of-references] 57
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5. Bachmann GA, Komi JO, Ospemifene Study Group: Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause; 2010 May-Jun;17(3):480-6
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study.
  • OBJECTIVE: The aim of this study was to study the efficacy and safety of ospemifene, a new selective estrogen receptor modulator, in the treatment of vulvovaginal atrophy in postmenopausal women.
  • METHODS: A randomized, double-blind phase 3 study in which 826 postmenopausal women were randomized 1:1:1 to receive treatment with ospemifene 30 or 60 mg/day or placebo orally for 12 weeks was conducted.
  • The primary inclusion criteria were having 5% or less superficial cells on the vaginal smear (maturation index), vaginal pH greater than 5.0, and at least one moderate or severe symptom of vulvovaginal atrophy.
  • CONCLUSIONS: Ospemifene was shown to be effective and well tolerated for the treatment of the symptoms of vaginal dryness and dyspareunia associated with vulvovaginal atrophy over and above the use of provided lubricants.
  • [MeSH-major] Selective Estrogen Receptor Modulators / administration & dosage. Tamoxifen / analogs & derivatives. Vagina / pathology. Vaginal Diseases / drug therapy. Vulva / pathology
  • [MeSH-minor] Atrophy / drug therapy. Dose-Response Relationship, Drug. Double-Blind Method. Drug Administration Schedule. Dyspareunia / drug therapy. Female. Humans. Middle Aged. Postmenopause. Treatment Outcome

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  • [CommentIn] Menopause. 2010 May-Jun;17(3):452-3 [20464782.001]
  • (PMID = 20032798.001).
  • [ISSN] 1530-0374
  • [Journal-full-title] Menopause (New York, N.Y.)
  • [ISO-abbreviation] Menopause
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Selective Estrogen Receptor Modulators; 094ZI81Y45 / Tamoxifen; B0P231ILBK / Ospemifene
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6. Simon JA, Reape KZ, Wininger S, Hait H: Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril; 2008 Oct;90(4):1132-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women.
  • OBJECTIVE: To evaluate the safety and efficacy of synthetic conjugated estrogens B (SCE-B; 0.3 mg/d) for 12 weeks in the treatment of vulvovaginal atrophy in symptomatic, postmenopausal women.
  • PATIENT(S): Postmenopausal women with at least one moderate to severe symptom of vaginal atrophy.
  • MAIN OUTCOME MEASURE(S): Mean changes in vaginal maturation index, percentage of parabasal and superficial cells, vaginal pH, and severity of the most bothersome symptom (MBS) between baseline and predetermined time points were assessed.
  • Synthetic conjugated estrogens B yielded statistically significantly greater differences in vaginal maturation index and vaginal pH from baseline to the end of treatment.
  • CONCLUSION(S): Synthetic conjugated estrogens B (0.3 mg/d) was effective in treating vulvovaginal atrophy in symptomatic postmenopausal women.
  • Significant improvement was seen in vaginal maturation index, vaginal pH, and severity of MBS from baseline to the end of treatment.
  • [MeSH-major] Estrogen Replacement Therapy / methods. Estrogens, Conjugated (USP) / administration & dosage. Postmenopause / drug effects. Vagina / drug effects. Vagina / pathology. Vulva / drug effects. Vulva / pathology
  • [MeSH-minor] Atrophy / drug therapy. Double-Blind Method. Female. Humans. Middle Aged. Placebo Effect. Treatment Outcome. United States

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  • (PMID = 18053998.001).
  • [ISSN] 1556-5653
  • [Journal-full-title] Fertility and sterility
  • [ISO-abbreviation] Fertil. Steril.
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00196378
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Estrogens, Conjugated (USP)
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7. Shulman LP: Selective estrogen receptor modulators and vulvovaginal atrophy: can we improve the lives of our patients with new therapeutic options? Menopause; 2010 May-Jun;17(3):452-3
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Selective estrogen receptor modulators and vulvovaginal atrophy: can we improve the lives of our patients with new therapeutic options?
  • [MeSH-major] Postmenopause. Selective Estrogen Receptor Modulators / administration & dosage. Vagina / pathology. Vaginal Diseases / drug therapy. Vulva / pathology. Women's Health
  • [MeSH-minor] Atrophy / drug therapy. Dose-Response Relationship, Drug. Female. Humans. Middle Aged. Treatment Outcome

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  • [CommentOn] Menopause. 2010 May-Jun;17(3):480-6 [20032798.001]
  • (PMID = 20464782.001).
  • [ISSN] 1530-0374
  • [Journal-full-title] Menopause (New York, N.Y.)
  • [ISO-abbreviation] Menopause
  • [Language] eng
  • [Publication-type] Comment; Editorial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Selective Estrogen Receptor Modulators
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8. Archer DF: Tissue-selective estrogen complexes: a promising option for the comprehensive management of menopausal symptoms. Drugs Aging; 2010 Jul 01;27(7):533-44
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Tissue-selective estrogen complexes: a promising option for the comprehensive management of menopausal symptoms.
  • At menopause many women experience undesired symptoms such as hot flashes and those associated with vulvovaginal atrophy, and are susceptible to loss of bone mass.
  • Menopausal therapies to date include various estrogen and estrogen-progestin (progesterone congener) formulations.
  • However, both physicians and women became concerned about hormone-related therapies following publication of data from the Women's Health Initiative.
  • Thus, the need exists for alternative therapies for postmenopausal women.
  • Tissue-selective estrogen complexes (TSECs) are the pairing of estrogen(s) with a selective estrogen receptor modulator (SERM).
  • This goal can potentially be achieved by the result of the different molecular and cellular activities of the treatment's estrogen and SERM components.
  • The therapeutic profile of a TSEC would optimally include relief of hot flashes, treatment of vulvovaginal atrophy and its symptoms, and prevention of bone loss, while providing safety for the endometrium and breast.
  • Recent data indicate that the TSEC containing the SERM bazedoxifene and conjugated estrogens relieves hot flashes, improves vulvovaginal atrophy and its symptoms, and prevents loss of bone mass without stimulating the endometrium.
  • This article reviews the current options for menopausal treatment as well as the environment that has driven the most recent evolution of new therapies for menopausal women, including the most recent development of the TSEC bazedoxifene and its early preclinical and clinical data.
  • [MeSH-major] Estrogens, Conjugated (USP) / therapeutic use. Menopause. Selective Estrogen Receptor Modulators / therapeutic use
  • [MeSH-minor] Aged. Animals. Drug Therapy, Combination. Estrogen Replacement Therapy / methods. Female. Hot Flashes / drug therapy. Humans. Indoles / adverse effects. Indoles / pharmacology. Indoles / therapeutic use. Middle Aged. Osteoporosis, Postmenopausal / prevention & control

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  • (PMID = 20583848.001).
  • [ISSN] 1179-1969
  • [Journal-full-title] Drugs & aging
  • [ISO-abbreviation] Drugs Aging
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Estrogens, Conjugated (USP); 0 / Indoles; 0 / Selective Estrogen Receptor Modulators; Q16TT9C5BK / bazedoxifene
  • [Number-of-references] 110
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9. Bachmann GA, Schaefers M, Uddin A, Utian WH: Microdose transdermal estrogen therapy for relief of vulvovaginal symptoms in postmenopausal women. Menopause; 2009 Sep-Oct;16(5):877-82
Hazardous Substances Data Bank. LEVONORGESTREL .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Microdose transdermal estrogen therapy for relief of vulvovaginal symptoms in postmenopausal women.
  • OBJECTIVE: The aim of this study was to investigate the effectiveness of microdose transdermal 17beta-estradiol (E2) therapy in postmenopausal women with moderate to severe vulvovaginal symptoms.
  • METHODS: This report is based on a subset of 121 women who reported most bothersome moderate or severe vulvovaginal symptoms at baseline, from a previous randomized, double-blind, placebo-controlled, multicenter study of 425 healthy, symptomatic, postmenopausal women.
  • Secondary efficacy variables reported herein include mean change from baseline in vaginal pH and vaginal maturation index, the proportion of women with symptoms of vulvar and vaginal atrophy at baseline and week 12, and the proportion of women with moderate-to-severe symptoms of vulvar and vaginal atrophy.
  • RESULTS: Microdose transdermal E2 treatment was associated with a consistent benefit versus placebo in women with vulvovaginal atrophy.
  • CONCLUSIONS: Microdose transdermal E2 offers a useful addition to the therapeutic armamentarium for postmenopausal women in whom vulvovaginal symptoms are particularly troublesome.
  • [MeSH-major] Estradiol / therapeutic use. Estrogen Replacement Therapy / methods. Postmenopause / drug effects. Vagina / drug effects. Vulva / drug effects
  • [MeSH-minor] Administration, Cutaneous. Adult. Aged. Analysis of Variance. Atrophy. Double-Blind Method. Female. Humans. Hydrogen-Ion Concentration. Levonorgestrel / therapeutic use. Middle Aged. Severity of Illness Index. Treatment Outcome. United States

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  • (PMID = 19458560.001).
  • [ISSN] 1530-0374
  • [Journal-full-title] Menopause (New York, N.Y.)
  • [ISO-abbreviation] Menopause
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 4TI98Z838E / Estradiol; 5W7SIA7YZW / Levonorgestrel
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10. McCall JL, DeGregorio MW: Pharmacologic evaluation of ospemifene. Expert Opin Drug Metab Toxicol; 2010 Jun;6(6):773-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Pharmacologic evaluation of ospemifene.
  • IMPORTANCE OF THE FIELD: Millions of women worldwide suffer from vulvovaginal atrophy (VVA) associated with menopause, and many women report that this adversely affects their quality of life.
  • Ospemifene is a non-hormonal estrogen receptor agonist/antagonist effective in the treatment of VVA.
  • This review focuses on ospemifene including its pharmacologic properties, clinical efficacy and safety.
  • TAKE HOME MESSAGE: The pharmacologic properties of ospemifene make it a logical candidate for the treatment of women with moderate to severe symptoms of VVA associated with menopause.
  • [MeSH-major] Atrophy / drug therapy. Tamoxifen / analogs & derivatives. Vagina / pathology. Vulva / pathology
  • [MeSH-minor] Female. Humans. Selective Estrogen Receptor Modulators / adverse effects. Selective Estrogen Receptor Modulators / pharmacology. Selective Estrogen Receptor Modulators / therapeutic use

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  • (PMID = 20429673.001).
  • [ISSN] 1744-7607
  • [Journal-full-title] Expert opinion on drug metabolism & toxicology
  • [ISO-abbreviation] Expert Opin Drug Metab Toxicol
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Selective Estrogen Receptor Modulators; 094ZI81Y45 / Tamoxifen; B0P231ILBK / Ospemifene
  • [Number-of-references] 41
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11. Holinka CF: Design and conduct of clinical trials in hormone replacement therapy. Ann N Y Acad Sci; 2001 Sep;943:89-108
The Lens. Cited by Patents in .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Design and conduct of clinical trials in hormone replacement therapy.
  • Postmenopausal hormone replacement therapy represents an area of outstanding importance in preventive medicine that greatly affects personal well-being as well as public health.
  • Many of those women are likely to be eligible for postmenopausal hormone replacement, which may consist either of estrogen replacement therapy (ERT) in women without a uterus or, more frequently, estrogen/progestin combination therapy (HRT) in women with a uterus.
  • This chapter first presents an overview of general regulatory requirements pertaining to the design and conduct of clinical studies in support of marketing approval for a drug product.
  • The chapter next discusses the design and conduct of clinical trials in support of marketing approval for the indications: treatment of moderate to severe vasomotor symptoms and vulvovaginal atrophy; prevention of osteoporosis; and protection by adjunctive progestin against estrogen-induced endometrial hyperplasia/cancer in women with a uterus.
  • [MeSH-major] Estrogen Replacement Therapy
  • [MeSH-minor] Animals. Clinical Trials as Topic. Drug Approval. Female. Humans. Pregnancy. Research Design

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  • (PMID = 11594562.001).
  • [ISSN] 0077-8923
  • [Journal-full-title] Annals of the New York Academy of Sciences
  • [ISO-abbreviation] Ann. N. Y. Acad. Sci.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Number-of-references] 77
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12. Archer DF: Lower doses of oral estrogen and progestogens as treatment for postmenopausal women. Semin Reprod Med; 2005 May;23(2):188-95
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Lower doses of oral estrogen and progestogens as treatment for postmenopausal women.
  • Estrogen, with or without a progestin, is effective for the treatment of menopausal symptoms.
  • Both positive and negative outcomes of hormone therapy are reported in postmenopausal women.
  • The positive aspects have been those associated with a reduction in menopausal symptoms such as hot flashes, and improvement in vulvovaginal atrophy with maintenance of bone mineral density.
  • [MeSH-major] Estrogen Replacement Therapy / methods. Estrogens / administration & dosage. Postmenopause / physiology. Progestins / administration & dosage
  • [MeSH-minor] Administration, Oral. Dose-Response Relationship, Drug. Female. Humans. United States. United States Food and Drug Administration

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  • (PMID = 15852205.001).
  • [ISSN] 1526-8004
  • [Journal-full-title] Seminars in reproductive medicine
  • [ISO-abbreviation] Semin. Reprod. Med.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Estrogens; 0 / Progestins
  • [Number-of-references] 82
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13. Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H: Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause; 2009 Jul-Aug;16(4):735-41
ClinicalTrials.gov. clinical trials - ClinicalTrials.gov .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy.
  • OBJECTIVE: The aim of this study was to evaluate low-dose synthetic conjugated estrogens A (SCE-A) cream administered twice weekly for the treatment of moderate to severe vulvovaginal atrophy (VVA) in a symptomatic postmenopausal population.
  • [MeSH-minor] Aged. Atrophy. Double-Blind Method. Dyspareunia / drug therapy. Female. Humans. Hydrogen-Ion Concentration. Middle Aged. Placebos. Vaginal Creams, Foams, and Jellies / administration & dosage. Vaginal Diseases / drug therapy

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  • (PMID = 19252451.001).
  • [ISSN] 1530-0374
  • [Journal-full-title] Menopause (New York, N.Y.)
  • [ISO-abbreviation] Menopause
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Estrogens, Conjugated (USP); 0 / Placebos; 0 / Vaginal Creams, Foams, and Jellies
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14. Gupta P, Ozel B, Stanczyk FZ, Felix JC, Mishell DR Jr: The effect of transdermal and vaginal estrogen therapy on markers of postmenopausal estrogen status. Menopause; 2008 Jan-Feb;15(1):94-7
The Lens. Cited by Patents in .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The effect of transdermal and vaginal estrogen therapy on markers of postmenopausal estrogen status.
  • Therefore, this patch is likely to relieve symptoms of vulvovaginal atrophy.
  • [MeSH-major] Estradiol / administration & dosage. Estrogen Replacement Therapy / methods. Estrogens / administration & dosage. Estrogens / blood. Postmenopause / drug effects
  • [MeSH-minor] Administration, Cutaneous. Administration, Intravaginal. Atrophy / drug therapy. Atrophy / pathology. Drug Delivery Systems / methods. Estrone / analogs & derivatives. Estrone / blood. Female. Follicle Stimulating Hormone / blood. Humans. Luteinizing Hormone / blood. Middle Aged. Prospective Studies. Sex Hormone-Binding Globulin / metabolism. Vagina / drug effects. Vagina / pathology. Vaginal Creams, Foams, and Jellies / administration & dosage

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  • (PMID = 17882008.001).
  • [ISSN] 1072-3714
  • [Journal-full-title] Menopause (New York, N.Y.)
  • [ISO-abbreviation] Menopause
  • [Language] eng
  • [Publication-type] Controlled Clinical Trial; Journal Article; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Estrogens; 0 / Sex Hormone-Binding Globulin; 0 / Vaginal Creams, Foams, and Jellies; 2DI9HA706A / Estrone; 4TI98Z838E / Estradiol; 9002-67-9 / Luteinizing Hormone; 9002-68-0 / Follicle Stimulating Hormone; QTL48N278K / estrone sulfate
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15. Bachmann G, Bouchard C, Hoppe D, Ranganath R, Altomare C, Vieweg A, Graepel J, Helzner E: Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. Menopause; 2009 Jul-Aug;16(4):719-27
COS Scholar Universe. author profiles.

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of low-dose conjugated estrogens (CE) cream for treatment of atrophic vaginitis.
  • METHODS: Postmenopausal women (N = 423) with moderate-to-severe vaginal atrophy were randomized to CE cream 0.3 mg or placebo once daily (21 days on/7 days off) or twice weekly for 12 weeks, followed by open-label treatment with CE cream for 40 weeks consistent with their prior regimen.
  • CONCLUSIONS: Daily and twice-weekly use of low-dose CE cream was equally effective in relieving symptoms of vulvovaginal atrophy.
  • Both regimens showed endometrial safety and sustained efficacy during 1 year of therapy.
  • [MeSH-major] Estrogens, Conjugated (USP) / administration & dosage. Postmenopause. Vaginitis / drug therapy
  • [MeSH-minor] Administration, Intravaginal. Aged. Aged, 80 and over. Double-Blind Method. Endometrial Hyperplasia / chemically induced. Endometrial Hyperplasia / pathology. Endometrial Hyperplasia / ultrasonography. Endometrium / drug effects. Endometrium / pathology. Endometrium / ultrasonography. Female. Humans. Hydrogen-Ion Concentration. Middle Aged. Placebos. Vaginal Creams, Foams, and Jellies / administration & dosage

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  • (PMID = 19436223.001).
  • [ISSN] 1530-0374
  • [Journal-full-title] Menopause (New York, N.Y.)
  • [ISO-abbreviation] Menopause
  • [Language] eng
  • [Publication-type] Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Estrogens, Conjugated (USP); 0 / Placebos; 0 / Vaginal Creams, Foams, and Jellies
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16. Curran MP, Wagstaff AJ: Estradiol and norgestimate: a review of their combined use as hormone replacement therapy in postmenopausal women. Drugs Aging; 2001;18(11):863-85
Hazardous Substances Data Bank. NORGESTREL .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Estradiol and norgestimate: a review of their combined use as hormone replacement therapy in postmenopausal women.
  • The focus of this review is hormone replacement therapy (HRT) with continuous administration of micronised, oral 17beta-estradiol 1 mg/day (herein referred to as continuous estradiol) plus micronised, oral norgestimate 90 microg/day administered for 3 days then withdrawn for 3 days in a 6-day repeating sequence (herein referred to as intermittent norgestimate).
  • According to data from randomised, comparative trials of 1 year's duration, continuous estradiol 1 mg/day plus intermittent norgestimate 90 microg/day relieves climacteric symptoms (vasomotor symptoms and vulvovaginal atrophy) in postmenopausal women.
  • Continuous estradiol 1 mg/day plus intermittent norgestimate 90 microg/day appeared as effective as estradiol 1 mg/day alone or continuous estradiol 2 mg/day plus continuous norethisterone acetate 1 mg/day in the treatment of postmenopausal women with vasomotor symptoms.
  • Continuous estradiol 1 mg/day plus intermittent oral norgestimate 90 microg/day was associated with a favourable uterine bleeding profile that improved over time.
  • In a randomised trial, 80% of women were free from bleeding (irrespective of spotting) during month 12 of treatment.
  • [MeSH-major] Contraceptives, Oral, Synthetic / therapeutic use. Estradiol / therapeutic use. Estrogen Replacement Therapy / statistics & numerical data. Norgestrel / analogs & derivatives. Norgestrel / therapeutic use
  • [MeSH-minor] Drug Therapy, Combination. Female. Humans

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  • [Cites] N Engl J Med. 1994 Apr 14;330(15):1062-71 [8127335.001]
  • (PMID = 11772126.001).
  • [ISSN] 1170-229X
  • [Journal-full-title] Drugs & aging
  • [ISO-abbreviation] Drugs Aging
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Contraceptives, Oral, Synthetic; 3J8Q1747Z2 / Norgestrel; 4TI98Z838E / Estradiol; C291HFX4DY / norgestimate
  • [Number-of-references] 107
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17. Mehta A, Bachmann G: Vulvovaginal complaints. Clin Obstet Gynecol; 2008 Sep;51(3):549-55
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Vulvovaginal complaints.
  • Overview of the etiology and diagnostic evaluation of vulvovaginal complaints in the postmenopausal population including both estrogen's role in atrophic vaginitis and other causes of vulvovaginal complaints and how they relate to sexual function.
  • [MeSH-major] Estrogen Replacement Therapy / methods. Estrogens / physiology. Menopause / physiology. Sexual Dysfunction, Physiological / prevention & control. Vaginal Diseases / prevention & control
  • [MeSH-minor] Aged. Atrophy / pathology. Atrophy / prevention & control. Female. Humans. Middle Aged. Postmenopause. Treatment Outcome. Vagina / drug effects. Vagina / pathology

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  • (PMID = 18677149.001).
  • [ISSN] 1532-5520
  • [Journal-full-title] Clinical obstetrics and gynecology
  • [ISO-abbreviation] Clin Obstet Gynecol
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Estrogens
  • [Number-of-references] 18
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18. Keil K: Urogenital atrophy: diagnosis, sequelae, and management. Curr Womens Health Rep; 2002 Aug;2(4):305-11

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Urogenital atrophy: diagnosis, sequelae, and management.
  • Some will not have any symptoms, while others may experience all of its debilitating side effects: hot flashes, osteoporosis, insomnia, irritability, depression, and urogenital atrophy.
  • This article discusses the many sequelae of urogenital atrophy: vulvovaginal irritation, urinary tract irritative symptoms and infection, urinary incontinence, and sexual dysfunction.
  • [MeSH-major] Female Urogenital Diseases / therapy. Postmenopause. Urogenital System / pathology
  • [MeSH-minor] Aged. Atrophy. Estrogen Replacement Therapy. Female. Humans. Lubrication. Sexual Dysfunction, Physiological / etiology. Sexual Dysfunction, Physiological / therapy. Urinary Incontinence / drug therapy. Urinary Incontinence / etiology

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  • (PMID = 12150759.001).
  • [ISSN] 1534-5874
  • [Journal-full-title] Current women's health reports
  • [ISO-abbreviation] Curr Womens Health Rep
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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19. Notelovitz M, Mattox JH: Suppression of vasomotor and vulvovaginal symptoms with continuous oral 17beta-estradiol. Menopause; 2000 Sep-Oct;7(5):310-7
Hazardous Substances Data Bank. ESTRADIOL .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Suppression of vasomotor and vulvovaginal symptoms with continuous oral 17beta-estradiol.
  • OBJECTIVES: To evaluate the efficacy and safety of different doses of 173-estradiol for the treatment of vasomotor and vulvovaginal symptoms.
  • RESULTS: There were significant differences between placebo and the active treatments in the percentage change from baseline in the number of hot flushes (all hot flushes, 1 mg vs. placebo, p < 0.00 1; 0.5 mg vs. placebo, p = 0.007), with a more substantial proportion of subjects responding in the 1-mg group (mean change in mean number of hot flushes of 83.2%).
  • Both doses were also more effective than placebo in increasing the proportion of mature vaginal cells (end-of-treatment mean values of 0%, 78.5%, and 21.5% for parabasal, intermediate, and superficial cells, respectively, in the 1-mg group; mean values of 0.3%, 80.8%, and 18.9% in the 0.5-mg group; and mean values of 15.2%, 74.7%, and 10.2% in the placebo group).
  • CONCLUSIONS: For the relief of vasomotor and vulvovaginal symptoms, 17beta-estradiol I mg is effective and has an excellent safety profile.
  • [MeSH-major] Estradiol / therapeutic use. Estrogen Replacement Therapy. Hot Flashes / prevention & control. Postmenopause. Vaginal Diseases / prevention & control. Vulvar Diseases / prevention & control
  • [MeSH-minor] Administration, Oral. Adult. Atrophy / prevention & control. Dose-Response Relationship, Drug. Double-Blind Method. Female. Humans. Middle Aged. United States. Vagina / drug effects. Vagina / pathology

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  • (PMID = 10993030.001).
  • [ISSN] 1072-3714
  • [Journal-full-title] Menopause (New York, N.Y.)
  • [ISO-abbreviation] Menopause
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 4TI98Z838E / Estradiol
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20. Del Pup L: [Treatment of atrophic and irritative vulvovaginal symptoms with an anhydrous lipogel and its complementary effect with vaginal estrogenic therapy: new evidences]. Minerva Ginecol; 2010 Aug;62(4):287-91
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Treatment of atrophic and irritative vulvovaginal symptoms with an anhydrous lipogel and its complementary effect with vaginal estrogenic therapy: new evidences].
  • [Transliterated title] Trattamento dei disturbi trofici e irritativi vulvovaginali con un lipogel anidro e suo effetto complementare alla terapia estrogenica per via vaginale: nuovi approfondimenti.
  • It is sometimes difficult to treat vulvovaginal itching and dryness, which represent frustrating symptoms for both patients and doctors.
  • In case that the etiological agent is Candida albicans, effective antimycotic therapies are available; however, itching is often caused by aspecific allergic-irritative factors, which are difficult to be defined.
  • Besides behavioral suggestions, a therapeutic support would be useful; medical doctors habitually prescribe local symptomatic treatments which, however, do not target numerous causes of irritative vulvovaginal symptomatology, though they are formulated for vulvovaginal application.
  • If there is estrogenic deficit, the best therapeutic approach is based on topical estrogenic therapy, which is sometimes ineffective on vulvar symptoms.
  • Frequently, it is necessary to choose a complementary therapeutic tool for vaginal application in order to alleviate itching, burning, erythema, dryness.
  • Results of this study, performed on 34-58-year-old patients, confirmed the efficacy of the lipogel on irritative vulvovaginal symptoms.
  • In postmenopausal women, the lipogel is a useful synergistic complement to topical hormonal therapy.
  • [MeSH-major] Estrogens / administration & dosage. Hydrogel / administration & dosage. Lipids / administration & dosage. Vulvovaginitis / drug therapy
  • [MeSH-minor] Administration, Intravaginal. Anti-Inflammatory Agents, Non-Steroidal / administration & dosage. Antifungal Agents / administration & dosage. Atrophy / drug therapy. Candidiasis, Vulvovaginal / drug therapy. Candidiasis, Vulvovaginal / pathology. Clinical Trials as Topic. Drug Combinations. Drug Therapy, Combination. Evidence-Based Medicine. Female. Humans. Ointments / administration & dosage. Pruritus / drug therapy. Severity of Illness Index. Treatment Failure. Treatment Outcome. Triterpenes / administration & dosage. Vitamin E / administration & dosage

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  • (PMID = 20827246.001).
  • [ISSN] 0026-4784
  • [Journal-full-title] Minerva ginecologica
  • [ISO-abbreviation] Minerva Ginecol
  • [Language] ita
  • [Publication-type] English Abstract; Journal Article; Review
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / Anti-Inflammatory Agents, Non-Steroidal; 0 / Antifungal Agents; 0 / Drug Combinations; 0 / Estrogens; 0 / Lipids; 0 / Ointments; 0 / Triterpenes; 1406-18-4 / Vitamin E; 25852-47-5 / Hydrogel; 631-69-6 / boswellic acid
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21. Archer DF: Efficacy and tolerability of local estrogen therapy for urogenital atrophy. Menopause; 2010 Jan-Feb;17(1):194-203
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Efficacy and tolerability of local estrogen therapy for urogenital atrophy.
  • METHODS: Medical literature on the incidence and treatment of vulvovaginal symptoms in postmenopausal women was reviewed.
  • RESULTS: Urogenital atrophy should not be considered an inevitable consequence of menopause because various hormonal and nonhormonal products are available to relieve symptoms.
  • Estrogen deficiency is the primary cause of atrophic urogenital changes, and postmenopausal estrogen therapy is the most logical choice for treatment.
  • Individualization of therapy is the key to balancing the desired local effects of topical vaginal estrogens with potential systemic effects, which may or may not be desired.
  • CONCLUSIONS: This article reviews the use of products for the management of urogenital atrophy in terms of their efficacy, safety, and other characteristics that may influence prescribing and woman's preference.
  • [MeSH-major] Estrogen Replacement Therapy. Estrogens / administration & dosage. Urinary Incontinence / drug therapy. Vaginal Diseases / drug therapy
  • [MeSH-minor] Administration, Intravaginal. Atrophy / drug therapy. Dyspareunia / drug therapy. Female. Humans. Middle Aged. Postmenopause. Urethra / pathology

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  • (PMID = 19602990.001).
  • [ISSN] 1530-0374
  • [Journal-full-title] Menopause (New York, N.Y.)
  • [ISO-abbreviation] Menopause
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Estrogens
  • [Number-of-references] 75
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22. Raghunandan C, Agrawal S, Dubey P, Choudhury M, Jain A: A comparative study of the effects of local estrogen with or without local testosterone on vulvovaginal and sexual dysfunction in postmenopausal women. J Sex Med; 2010 Mar;7(3):1284-90
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A comparative study of the effects of local estrogen with or without local testosterone on vulvovaginal and sexual dysfunction in postmenopausal women.
  • INTRODUCTION: A significant number of postmenopausal women suffer from distressing problems because of urogenital atrophy secondary to the decline in circulating estrogen levels.
  • Treatment with topical hormones may provide relief in such women when used judiciously.
  • METHODS: Seventy-five postmenopausal women symptomatic for urogenital atrophy and sexual dysfunction were randomly divided into two study groups and one control group.
  • The women in study group 1 received local estrogen cream; study group 2 received local estrogen and testosterone cream; the control group received nonhormonal lubricant KY gel for 12 weeks.
  • The urogenital and sexuality score, along with the vaginal health index and the vaginal maturation index (VMI), was calculated at the beginning of therapy and 12 weeks later.
  • RESULTS: After 12 weeks of therapy, there was a significant improvement in all the four study parameters, which correlated well with the improvement in symptoms of urogenital atrophy and sexual dysfunction in both the study groups as compared with the control group.
  • Improvement in sexuality score was greatest with combined estrogen-androgen therapy.
  • There were no adverse effects and the therapies were well accepted without any compliance issue.
  • CONCLUSION: Local estrogen either alone or with androgen is highly effective in relieving symptoms of urogenital atrophy and in improving sexual function in symptomatic postmenopausal women.
  • [MeSH-major] Estrogens / therapeutic use. Postmenopause / physiology. Sexual Dysfunctions, Psychological / drug therapy. Testosterone / therapeutic use. Vaginal Diseases / drug therapy

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  • (PMID = 20102444.001).
  • [ISSN] 1743-6109
  • [Journal-full-title] The journal of sexual medicine
  • [ISO-abbreviation] J Sex Med
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Estrogens; 3XMK78S47O / Testosterone
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23. Stika CS: Atrophic vaginitis. Dermatol Ther; 2010 Sep-Oct;23(5):514-22
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • With the loss of estrogen that occurs with menopause, physiologic and structural changes occur within the vulvovaginal mucosa that lead to a condition commonly called atrophic vaginitis.
  • Although mild genital changes occur in most women, 10-47% of postmenopausal women will develop one or more debilitating symptoms that include vulvovaginal dryness, dyspareunia, vulvar itching or pain, recurrent urinary tract infections, as well as abnormal vaginal discharge.
  • Topical estrogen replacement therapies reverse these mucosal changes and are effective treatments for the symptoms of atrophic vaginitis.
  • [MeSH-minor] Antineoplastic Agents, Hormonal / pharmacology. Atrophy. Breast Neoplasms / complications. Breast Neoplasms / drug therapy. Epithelial Cells / cytology. Epithelium / anatomy & histology. Estrogen Replacement Therapy. Estrogens / administration & dosage. Estrogens / deficiency. Estrogens / physiology. Female. Gynecological Examination. Humans. Lipids / therapeutic use. Menopause / physiology. Selective Estrogen Receptor Modulators / pharmacology. Vaginal Creams, Foams, and Jellies / therapeutic use

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  • [Copyright] © 2010 Wiley Periodicals, Inc.
  • (PMID = 20868405.001).
  • [ISSN] 1529-8019
  • [Journal-full-title] Dermatologic therapy
  • [ISO-abbreviation] Dermatol Ther
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Denmark
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Hormonal; 0 / Estrogens; 0 / Lipids; 0 / Replens; 0 / Selective Estrogen Receptor Modulators; 0 / Vaginal Creams, Foams, and Jellies
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24. Pinkerton JV, Stovall DW: Bazedoxifene when paired with conjugated estrogens is a new paradigm for treatment of postmenopausal women. Expert Opin Investig Drugs; 2010 Dec;19(12):1613-21
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Bazedoxifene when paired with conjugated estrogens is a new paradigm for treatment of postmenopausal women.
  • IMPORTANCE OF THE FIELD: The concept of the tissue selective estrogen complex (TSEC) combining a selective estrogen receptor modulator (SERM) with one or more estrogens, aims to provide comparable efficacy to combination estrogen and progestin therapy for symptomatic menopausal women with a uterus without the need for a progestin.
  • AREAS COVERED IN THIS REVIEW: Published multi-center randomized blinded clinical trials with bazedoxifene alone and paired in combination with conjugated estrogens show an effect in hot flashes, vaginal atrophy, quality of life measures, sleep, bone density, and breast and uterine safety.
  • Preclinical studies with bazedoxifene alone showed that it was antagonistic in the uterine and breast tissue while an agonist in the bone.
  • TAKE HOME MESSAGE: Bazedoxifene paired with conjugated estrogens in postmenopausal women relieves vasomotor symptoms and vulvovaginal atrophic changes with prevention of bone loss.
  • [MeSH-major] Estrogens, Conjugated (USP) / administration & dosage. Indoles / administration & dosage. Postmenopause / drug effects. Selective Estrogen Receptor Modulators / administration & dosage
  • [MeSH-minor] Animals. Clinical Trials as Topic / methods. Drug Therapy, Combination. Female. Hot Flashes / drug therapy. Hot Flashes / metabolism. Humans. Osteoporosis, Postmenopausal / metabolism. Osteoporosis, Postmenopausal / prevention & control. Treatment Outcome

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  • (PMID = 21073353.001).
  • [ISSN] 1744-7658
  • [Journal-full-title] Expert opinion on investigational drugs
  • [ISO-abbreviation] Expert Opin Investig Drugs
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Estrogens, Conjugated (USP); 0 / Indoles; 0 / Selective Estrogen Receptor Modulators; Q16TT9C5BK / bazedoxifene
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25. Brzezinski A, Benshushan A: Estrogen for vulvovaginal symptoms: how low can you go? Menopause; 2009 Sep-Oct;16(5):848-50

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Estrogen for vulvovaginal symptoms: how low can you go?
  • [MeSH-major] Estrogen Replacement Therapy / methods. Patient Selection. Postmenopause / drug effects. Vagina / drug effects. Vulva / drug effects
  • [MeSH-minor] Administration, Cutaneous. Administration, Intravaginal. Administration, Oral. Atrophy. Chemistry, Pharmaceutical. Female. Humans. Practice Guidelines as Topic

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  • (PMID = 19564805.001).
  • [ISSN] 1530-0374
  • [Journal-full-title] Menopause (New York, N.Y.)
  • [ISO-abbreviation] Menopause
  • [Language] eng
  • [Publication-type] Editorial; Review
  • [Publication-country] United States
  • [Number-of-references] 21
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