A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

Study Overview
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Brief Summary
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The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5 mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in Phase II.

Official Title
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Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo

Conditions
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Atrophy, Vaginal Diseases

Intervention / Treatment
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* Drug: Placebo
* Drug: Ospemifene 5 mg
* Drug: Ospemifene 15 mg
* Drug: Ospemifene 30 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Naturally or surgically menopausal Vaginal pH greater than 5.0 5% or fewer superficial cells in maturation index of vaginal smear Exclusion Criteria: Evidence of endometrial hyperplasia, cancer or other pathology Abnormal PAP smear Uterine bleeding of unknown origin or uterine polyps Current vaginal infection requiring medication Use of hormonal medications Clinically significant abnormal gynecological findings other than signs of vaginal atrophy

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 |
| --- | --- |
| Placebo Comparator: Subjects on placebo<br>Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks | Drug: Placebo<br>* 1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).<br>|
| Experimental: Subjects on ospemifene 5 mg/day<br>Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks | Drug: Ospemifene 5 mg<br>* 1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).<br>|
| Experimental: Subjects on ospemifene 15 mg/day<br>Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks | Drug: Ospemifene 15 mg<br>* 1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).<br>|
| Experimental: Subjects on ospemifene 30 mg/day<br>Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks | Drug: Ospemifene 30 mg<br>* 1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear |  | 12 weeks | 
| Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear |  | 12 weeks | 
| Mean Change From Baseline in Vaginal pH |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Evaluation of Vagina (by Gynecological Examination) |  | Screening & Week 12 | 
| Mean Change From Baseline in Vaginal pH |  | Week 4 | 
| Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index |  | Week 4 | 
| Mean Change From Baseline in Estradiol Levels |  | Week 12 | 
| Mean Change From Baseline in Luteinizing Hormone Levels |  | Week 12 | 
| Mean Change From Baseline in Follicle Stimulating Hormone Levels |  | Week 12 | 
| Mean Change From Baseline in Sex Hormone Binding Globulin Levels |  | Week 12 | 
| Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index |  | Week 4 | 

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