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

Phase 4

Terminated

Conditions: Sexual Dysfunction, Physiological

Interventions: Drug: Vaginal conjugated estrogens
Drug: Ospemifene

Registration Number: NCT03018106

Lead Sponsor: Emory University

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 Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 1

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estrogen	Vaginal conjugated estrogens	Women randomized to this arm will receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
Ospemifene	Ospemifene	Women randomized to this arm will receive 60mg oral ospemifene, taken daily, for 12 weeks

Primary Outcome Measures

Name	Time	Method
Pain With Sex	Baseline, Week 12	Participants reported pain with sex at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Female Sexual Function Index Score	Baseline, 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. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD).
Vaginal Itching	Baseline, Week 12	Participants reported vaginal itching at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Vaginal Irritation	Baseline, Week 12	Participants reported vaginal irritation at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Vaginal Dryness	Baseline, Week 12	Participants reported vaginal dryness at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): Emory Hospital
🇺🇸
Atlanta, Georgia, United States
Emory Midtown Hospital
🇺🇸
Atlanta, Georgia, United States
Emory Clinic
🇺🇸
Atlanta, Georgia, United States
Emory St. Joseph's Hospital
🇺🇸
Atlanta, Georgia, United States