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

Sponsor
Emory University (Other)
Overall Status
Terminated
CT.gov ID
NCT03018106
Collaborator
(none)
1
4
2
3
0.3
0.1

Study Details

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
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
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 :
Jun 30, 2017
Actual Primary Completion Date :
Sep 29, 2017
Actual Study Completion Date :
Sep 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 Names:
  • 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 Names:
  • Premarin Vaginal Cream
  • Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Emory Midtown Hospital Atlanta Georgia United States 30308
    2 Emory Clinic Atlanta Georgia United States 30322
    3 Emory Hospital Atlanta Georgia United States 30322
    4 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)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gina Northington, Associate Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT03018106
    Other Study ID Numbers:
    • IRB00088077
    First Posted:
    Jan 11, 2017
    Last Update Posted:
    Jan 23, 2018
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Associate Professor, Emory University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled between June 2017 and September 2017
    Pre-assignment Detail One individual gave informed consent to participate in the study and was randomized to the Estrogen arm.
    Arm/Group Title Ospemifene Estrogen
    Arm/Group Description Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
    Period Title: Overall Study
    STARTED 0 1
    COMPLETED 0 0
    NOT COMPLETED 0 1

    Baseline Characteristics

    Arm/Group Title Ospemifene Estrogen Total
    Arm/Group Description Women randomized to this arm were to receive 60mg oral ospemifene, taken daily, for 12 weeks Women randomized to this arm were to receive 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks Total of all reporting groups
    Overall Participants 0 1 1
    Age (Count of Participants)
    <=18 years
    0
    NaN
    0
    0%
    Between 18 and 65 years
    1
    Infinity
    1
    100%
    >=65 years
    0
    NaN
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51
    (0.0)
    51
    (0.0)
    Sex: Female, Male (Count of Participants)
    Female
    1
    Infinity
    1
    100%
    Male
    0
    NaN
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    NaN
    0
    0%
    Not Hispanic or Latino
    1
    Infinity
    1
    100%
    Unknown or Not Reported
    0
    NaN
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    NaN
    0
    0%
    Asian
    1
    Infinity
    1
    100%
    Native Hawaiian or Other Pacific Islander
    0
    NaN
    0
    0%
    Black or African American
    0
    NaN
    0
    0%
    White
    0
    NaN
    0
    0%
    More than one race
    0
    NaN
    0
    0%
    Unknown or Not Reported
    0
    NaN
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    1
    Infinity
    1
    100%

    Outcome Measures

    1. Primary Outcome
    Title Female Sexual Function Index Score
    Description 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).
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    The single participant was lost to follow up prior to completing the Week 12 assessment.
    Arm/Group Title Estrogen
    Arm/Group Description Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
    Measure Participants 1
    Baseline
    9
    2. Primary Outcome
    Title Pain With Sex
    Description 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.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    The single participant was lost to follow up prior to completing the Week 12 assessment.
    Arm/Group Title Estrogen
    Arm/Group Description Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
    Measure Participants 1
    Baseline
    2
    3. Primary Outcome
    Title Vaginal Dryness
    Description 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.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    The single participant was lost to follow up prior to completing the Week 12 assessment.
    Arm/Group Title Estrogen
    Arm/Group Description Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
    Measure Participants 1
    Baseline
    3
    4. Primary Outcome
    Title Vaginal Itching
    Description 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.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    The single participant was lost to follow up prior to completing the Week 12 assessment.
    Arm/Group Title Estrogen
    Arm/Group Description Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
    Measure Participants 1
    Baseline
    3
    5. Primary Outcome
    Title Vaginal Irritation
    Description 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.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    The single participant was lost to follow up prior to completing the Week 12 assessment.
    Arm/Group Title Estrogen
    Arm/Group Description Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
    Measure Participants 1
    Baseline
    3

    Adverse Events

    Time Frame Adverse event data were collected from the time the participant consented to take part in the study through the Week 12 Visit.
    Adverse Event Reporting Description
    Arm/Group Title Estrogen
    Arm/Group Description Women randomized to this arm received 0.5mg vaginal conjugated estrogens, placed vaginally twice per week, for 12 weeks
    All Cause Mortality
    Estrogen
    Affected / at Risk (%) # Events
    Total 0/1 (0%)
    Serious Adverse Events
    Estrogen
    Affected / at Risk (%) # Events
    Total 0/1 (0%)
    Other (Not Including Serious) Adverse Events
    Estrogen
    Affected / at Risk (%) # Events
    Total 0/1 (0%)

    Limitations/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.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Gina Northington, MD
    Organization Emory University
    Phone (404) 778-5770
    Email gina.northington@emory.edu
    Responsible Party:
    Gina Northington, Associate Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT03018106
    Other Study ID Numbers:
    • IRB00088077
    First Posted:
    Jan 11, 2017
    Last Update Posted:
    Jan 23, 2018
    Last Verified:
    Nov 1, 2017