Ospemifene in clinical practice for vulvo-vaginal atrophy: results at 3 months of follow-up of use

Pingarrón, Carmen; Lafuente, P.; Ierullo, A. M.; Torcal, Silvia Poyo; Díaz, Carlos Javier Maroto; Palacios, Santiago

doi:10.1080/09513590.2020.1853695

Cited by 5 publications

(4 citation statements)

References 22 publications

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“…1), resulting in 143 publications. Of these publications, we reviewed eight comparative studies 10–17 and four single-group studies 18–21 for vaginal DHEA, 13 comparative studies 22–34 and eight single-group studies 35–42 for oral ospemifene, 11 comparative studies 43–53 and 41 single-group studies 54–94 for microablative fractional carbon dioxide (CO 2 ) laser, two comparative studies 95,96 and three single-group studies 97–99 for Erbium:YAG laser, seven comparative studies 100-106 and one single-group study 107 for the polycarbophil-based vaginal moisturizer, six comparative studies 108–113 and one single-group study 114 for testosterone, 25 comparative studies 115–138 for oral tibolone, and seven comparative studies 139–145 and five single-group studies 146–150 for vaginal hyaluronic acid. A list of reviewed publications can be found in Appendix 2 (available online at http://links.lww.com/AOG/D289), and summarized findings can be found in Tables 1 and 2.…”

Section: Resultsmentioning

confidence: 99%

“…Ospemifene (30, 60, or 90 mg orally daily) was compared with placebo or no medication in 13 studies, and eight additional studies were single-group studies. 22–42 Change in the percentage of superficial and basal cells was reported in seven studies (n=2,545, high quality of evidence) where ospemifene was favored over placebo and a dose–response effect was noted. 24,25,28–31,34 With regards to lowering vaginal pH, ospemifene was also favored in six studies that compared ospemifene to placebo 24,25,28–30 (n=2,605, high quality of evidence), and a dose–response effect was again noted.…”

Section: Resultsmentioning

confidence: 99%

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Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause

Evans

Hobson

Aschkenazi

et al. 2023

Obstetrics &Amp; Gynecology

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OBJECTIVE: To systematically review the literature and provide clinical practice guidelines regarding various nonestrogen therapies for treatment of genitourinary syndrome of menopause (GSM). DATA SOURCES: MEDLINE, EMBASE, ClinicalTrials.gov, and Cochrane databases were searched from inception to July 2021. We included comparative and noncomparative studies. Interventions and comparators were limited to seven products that are commercially available and currently in use (vaginal dehydroepiandrosterone [DHEA], ospemifene, laser or energy-based therapies, polycarbophil-based vaginal moisturizer, Tibolone, vaginal hyaluronic acid, testosterone). Topical estrogen, placebo, other nonestrogen products, as well as no treatment were considered as comparators. METHODS OF STUDY SELECTION: We double-screened 9,131 abstracts and identified 136 studies that met our criteria. Studies were assessed for quality and strength of evidence by the systematic review group. TABULATION, INTEGRATION, AND RESULTS: Information regarding the participants, details on the intervention and comparator and outcomes were extracted from the eligible studies. Alternative therapies were similar or superior to estrogen or placebo with minimal increase in adverse events. Dose response was noted with vaginal DHEA and testosterone. Vaginal DHEA, ospemifene, erbium and fractional carbon dioxide (CO2) laser, polycarbophil-based vaginal moisturizer, tibolone, hyaluronic acid, and testosterone all improved subjective and objective signs of atrophy. Vaginal DHEA, ospemifene, tibolone, fractional CO2 laser, polycarbophil-based vaginal moisturizer, and testosterone improved sexual function. CONCLUSION: Most nonestrogen therapies are effective treatments for the various symptoms of GSM. There are insufficient data to compare nonestrogen options to each other.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause

Evans

Hobson

Aschkenazi

et al. 2023

Obstetrics &Amp; Gynecology

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“…Ospemifene, FDA approved since 2013, is a selective estrogen receptor agonist/antagonist, and is the only oral therapy specifically approved for the treatment of GSM. Daily administration of 60 mg of oral ospemifene in randomized trials was shown to improve dyspareunia, vaginal maturation, and vaginal pH [28–30]. In a 52-week efficacy and safety study of 180 individuals there were no cases of VTE, endometrial hyperplasia, or cancer [31].…”

Section: Systemic Hormone Therapymentioning

confidence: 99%

Pharmacologic therapeutic options for sexual dysfunction

Burton¹,

Mishra

2022

Current Opinion in Obstetrics &Amp; Gynecology

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Purpose of reviewSexual problems are reported by up to 45% of individuals assigned female at birth. Although sexual function is a complex biopsychosocial construct, there are a number of pharmacologic treatment options aimed at addressing the changing vaginal hormonal milieu in postmenopausal individuals and moderating the excitatory and inhibitory aspects of the central nervous system in those with hypoactive sexual desire disorder.Recent findingsThe last decade has seen an increase in the number and type of pharmacologic treatment options for dysfunction primarily associated with menopause and hypoactive sexual desire disorder. Recent publications and systematic reviews have strengthened the safety data of existing FDA-approved medications as well as off-label therapies.SummaryPharmacologic treatment with local estrogen and testosterone replacement in postmenopausal individuals and with centrally-acting therapies such as flibanserin, bremelanotide, and testosterone in premenopausal individuals assigned female at birth are safe and can be used to improve sexual desire and sexual satisfaction.

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“…To prevent side-effects, local treatment with E2-containing creams is available; however, systemic administration of selective compounds can be also beneficial. For example, ospemifene, a SERM, during a 3-month treatment significantly improved GSM, sexual function, and quality of life in general [341]. Thus, it is recommended for treatment of dyspareunia, persistent or recurrent genital pain that occurs just before, during, or after sex [141].…”

Section: Atrophy Of the Outer Barrier (Skin Mucosa) And Hairmentioning

confidence: 99%

Estradiol and Estrogen-like Alternative Therapies in Use: The Importance of the Selective and Non-Classical Actions

et al. 2022

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Estrogen is one of the most important female sex hormones, and is indispensable for reproduction. However, its role is much wider. Among others, due to its neuroprotective effects, estrogen protects the brain against dementia and complications of traumatic injury. Previously, it was used mainly as a therapeutic option for influencing the menstrual cycle and treating menopausal symptoms. Unfortunately, hormone replacement therapy might be associated with detrimental side effects, such as increased risk of stroke and breast cancer, raising concerns about its safety. Thus, tissue-selective and non-classical estrogen analogues have become the focus of interest. Here, we review the current knowledge about estrogen effects in a broader sense, and the possibility of using selective estrogen-receptor modulators (SERMs), selective estrogen-receptor downregulators (SERDs), phytoestrogens, and activators of non-genomic estrogen-like signaling (ANGELS) molecules as treatment.

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Ospemifene in clinical practice for vulvo-vaginal atrophy: results at 3 months of follow-up of use

Cited by 5 publications

References 22 publications

Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause

Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause

Pharmacologic therapeutic options for sexual dysfunction

Estradiol and Estrogen-like Alternative Therapies in Use: The Importance of the Selective and Non-Classical Actions

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