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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ospemifene Versus Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction

Brief 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.

Detailed Summary:

Female sexual dysfunction (FSD) affects 57% of postmenopausal women. Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing postmenopausal female population, and the most common symptom is dyspareunia. Women with FSD are 3.84 times as likely to also have VVA. 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. This oral medication, taken daily, improves vaginal health, and has demonstrated protective activity in the breast and bone tissues. It also has not demonstrated any carcinogenic activity in the endometrium or liver. This study hopes to determine if ospemifene is superior to conjugated estrogens in improving sexual function and vaginal atrophy symptoms.

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. Each participant will be informed of her assigned medication, and will receive a medication coupon to help offset the cost of the medication. Each medication is FDA-approved for long-term use of at least 52 weeks. For this study, a 12-week prescription for the medication will be sent electronically to the pharmacy of the participant's choice. The improvements in sexual health and VVA symptom severity will be compared in each group.


Sponsor: Emory University

Current Primary Outcome:

  • Change in Female Sexual Function Index score between groups [ Time Frame: Baseline and at Week 12 ]
    The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Participants will complete the questionnaire at the Baseline visit and after 12 weeks of treatment.
  • Change in pain with sex between groups [ Time Frame: Baseline and at Week 12 ]
    Participants will report pain with sex at the Baseline Visit and after 12 weeks of treatment. Participants will select from options of "none", "mild", "moderate", or "severe" when reporting the severity of their symptoms.
  • Change in vaginal dryness between groups [ Time Frame: Baseline and at Week 12 ]
    Participants will report vaginal dryness at the Baseline Visit and after 12 weeks of treatment. Participants will select from options of "none", "mild", "moderate", or "severe" when reporting the severity of their symptoms.
  • Change in vaginal itching between groups [ Time Frame: Baseline and at Week 12 ]
    Participants will report vaginal itching at the Baseline Visit and after 12 weeks of treatment. Participants will select from options of "none", &qu

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Emory University

    Dates:
    Date Received: January 10, 2017
    Date Started: January 2017
    Date Completion: August 2017
    Last Updated: March 16, 2017
    Last Verified: March 2017