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

NCT03018106 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00088077
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 4

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.

Conditions

Sexual Dysfunction, Physiological

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Female Sexual Function Index Score

  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).

  Baseline, Week 12

• Pain With Sex

  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.

  Baseline, Week 12

• Vaginal Dryness

  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.

  Baseline, Week 12

• Vaginal Itching

  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.

  Baseline, Week 12

• Vaginal Irritation

  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.

  Baseline, Week 12

Study Arms (2)

Ospemifene

EXPERIMENTAL

Women randomized to this arm will receive 60mg oral ospemifene, taken daily, for 12 weeks

Drug: Ospemifene

Estrogen

ACTIVE COMPARATOR

Women randomized to this arm will receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks

Drug: Vaginal conjugated estrogens

Interventions

Ospemifene DRUG

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.

Also known as: Osphena

Ospemifene

Vaginal conjugated estrogens DRUG

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).

Also known as: Premarin Vaginal Cream

Estrogen

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (4)

Emory Midtown Hospital

Atlanta, Georgia, 30308, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Related Publications (1)

• Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.

  PMID: 37619252 DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Ospemifene

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Limitations and Caveats

The patient population did not provide as many interested and qualified subjects as anticipated, thus the study was terminated early due to obstacles with recruitment and time limitations for data analyses.

Results Point of Contact

• Title: Gina Northington, MD
• Organization: Emory University

gina.northington@emory.edu

(404) 778-5770

Study Officials

• Gina Northington, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: June 30, 2017
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: January 23, 2018
• Results First Posted: December 20, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)