Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.

Official Title
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Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women

Conditions
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Atrophy, Vaginal Diseases

Intervention / Treatment
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* Drug: Ospemifene 60 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Naturally or surgically menopausal Moderate or severe symptoms of vaginal atrophy 5% or fewer superficial cells in maturation index of vaginal smear Vaginal pH greater than 5.0 Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization Exclusion Criteria: Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids Current vaginal infection requiring medication Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g. uterine or vaginal prolapse of Grade 2 or higher) Previous participation in any other ospemifene study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ospemifene 60 mg/day and K-Y® lubricant<br>Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. | Drug: Ospemifene 60 mg<br>* 60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed<br>* Other names: Osphena®;|
| Placebo Comparator: Placebo and K-Y® lubricant<br>Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. | Drug: Placebo<br>* oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) |  | 12 weeks | 
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) |  | 12 weeks | 
| Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) |  | 12 weeks | 
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) |  | 12 weeks | 
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) |  | 12 weeks | 
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) |  | 12 weeks | 
| Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) |  | 12 weeks | 
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) |  | 4 weeks | 
| Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) |  | 4 weeks | 
| Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) |  | 4 weeks | 
| Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) |  | 4 weeks | 
| Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) |  | 4 weeks | 
| Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) |  | 4 weeks | 
| Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) |  | 4 weeks | 
| Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvar and vaginal atrophy in postmenopausal women, Menopausal symptoms, Vaginal atrophy, Urogenital atrophy