Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction

• Status: Terminated
• Trial end date: 2017-09-29
• Target enrollment: 0
• Participant gender: Female

Summary

Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing postmenopausal female population, and the most common symptom is dyspareunia. Vaginal estrogen is the most common treatment for VVA, but it only marginally improves overall sexual function, and many women and clinicians avoid using it because of the risks of exogenous estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen receptor modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and has shown superb improvements in overall sexual health. 104 women will be randomized to receive 12 weeks of 60mg oral ospemifene, taken daily, or 12 weeks of 0.5mg vaginal conjugated estrogens, which is placed vaginally twice per week. The improvements in sexual health and VVA symptom severity will be compared in each group. This study will help determine if ospemifene is a better treatment medication than conjugated estrogens.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Estrogens; Estrogens, Conjugated (USP); Tamoxifen

Criteria

Inclusion Criteria:

• Interested in resuming or continuing sexual activity

• Greater than 12 months since last menstrual cycle or prior bilateral oophorectomy

• Dyspareunia as a vulvovaginal atrophy symptom

• Normal mammogram within 12 months prior to entry into the study

Exclusion Criteria:

• History or suspicion of breast carcinoma

• History of hormone-dependent tumor

• Genital bleeding of unknown cause

• Ongoing vaginal infection

• History of cerebrovascular accident (CVA), myocardial infarction (MI) or heart disease

• Uncontrolled hypertension (HTN) over 160/100

• Serious disease or chronic condition that may prevent completion of study

• Body Mass Index (BMI) over 40

• Hypercoagulable state, or currently on anticoagulant therapy

• Use of any exogenous sex hormone within three months from study entry, or during the study

• Pelvic surgery within the last 12 months