A Clinical Study to Evaluate the Safety of Ospemifene

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.

Official Title
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Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo

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 Intact uterus 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 |
| --- | --- |
| Experimental: Ospemifene 60 mg/day<br>Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks. | Drug: Ospemifene 60 mg<br>* 60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.<br>* Other names: Osphena®;|
| Placebo Comparator: Placebo<br>Placebo will be taken once daily, in the morning, with food for 52 weeks. | Drug: Placebo<br>* Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)<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 Maturation Index of Vaginal Smear |  | 12 weeks | 
| Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear |  | 12 weeks | 
| Mean Change From Baseline in Vaginal pH |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Estradiol Levels |  | 52 weeks | 
| Change From Baseline in Luteinizing Hormone Levels |  | 52 weeks | 
| Change From Baseline in Follicle Stimulating Hormone Levels |  | 52 weeks | 
| Change From Baseline in Sex Hormone Binding Globulin Levels |  | 52 weeks | 
| Visual Evaluation of the Vagina (Baseline & Week 52) |  | 52 weeks | 

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