Clinical trial NCT03018106: Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction
Official title: Ospemifene Versus Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sexual Dysfunction, Physiological
Keywords: Female sexual disorder
Aging
Menopause
Obstetrics/Gynecology
Female urogenital disorder
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 1
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Female Sexual Function Index Score
timeFrame: Baseline, Week 12
measure: Pain With Sex
timeFrame: Baseline, Week 12
measure: Vaginal Dryness
timeFrame: Baseline, Week 12
measure: Vaginal Itching
timeFrame: Baseline, Week 12
measure: Vaginal Irritation
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Midtown Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Gina Northington, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: