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

• ClinicalTrials.gov Identifier: NCT03018106
• Recruitment Status: Terminated
• First Posted: January 11, 2017
• Results First Posted: December 20, 2017
• Last Update Posted: January 23, 2018
• Sponsor: Emory University
• Information provided by (Responsible Party): Gina Northington, Emory University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sexual Dysfunction, Physiological	Drug: Ospemifene; Drug: Vaginal conjugated estrogens	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ospemifene Versus Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction
• Actual Study Start Date: June 30, 2017
• Actual Primary Completion Date: September 29, 2017
• Actual Study Completion Date: September 29, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ospemifene; Women randomized to this arm will receive 60mg oral ospemifene, taken daily, for 12 weeks	Drug: Ospemifene; Ospemifene is a selective estrogen receptor modulator (SERM), and it is the only SERM approved in the United States to treat moderate to severe dyspareunia associated with VVA. It is an oral medication that is taken as a 60mg tablet once daily. Food intake increases its absorption by 2 to 3-fold, and this is not impacted by the fat or calorie content of the food. It is metabolized primarily in the liver, and is excreted in feces.; Other Name: Osphena
Active Comparator: Estrogen; Women randomized to this arm will receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks	Drug: Vaginal conjugated estrogens; Conjugated estrogens are a mixture of several different estrogen salts derived from natural sources and blended to approximate the composition of estrogens in the urine of pregnant horses. The main components are sodium estrone sulphate and sodium equilin sulfate. Vaginal estrogen is considered the medication of choice for treating vulvovaginal atrophy (VVA).; Other Name: Premarin Vaginal Cream

Outcome Measures

Primary Outcome Measures :

1. Female Sexual Function Index Score [ Time Frame: 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).
2. Pain With Sex [ Time Frame: 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.
3. Vaginal Dryness [ Time Frame: 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.
4. Vaginal Itching [ Time Frame: 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.
5. Vaginal Irritation [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Georgia

Emory Midtown Hospital

Atlanta, Georgia, United States, 30308

Emory Clinic

Atlanta, Georgia, United States, 30322

Emory Hospital

Atlanta, Georgia, United States, 30322

Emory St. Joseph's Hospital

Atlanta, Georgia, United States, 30342

Sponsors and Collaborators

Emory University

Investigators

• Principal Investigator: Gina Northington, MD, PhD; Emory University

  Study Documents (Full-Text)

Documents provided by Gina Northington, Emory University:

Study Protocol and Statistical Analysis Plan  [PDF] November 27, 2017

More Information

• Responsible Party: Gina Northington, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT03018106
• Other Study ID Numbers: IRB00088077
• First Posted: January 11, 2017
• Results First Posted: December 20, 2017
• Last Update Posted: January 23, 2018
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gina Northington, Emory University:

Female sexual disorder; Aging; Menopause; Obstetrics/Gynecology; Female urogenital disorder

Additional relevant MeSH terms:

Sexual Dysfunction, Physiological; Estrogens; Estrogens, Conjugated (USP); Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs