A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

Study Overview
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Brief Summary
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The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Official Title
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Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo

Conditions
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Atrophy, Vaginal Diseases

Intervention / Treatment
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* Drug: Ospemifene 30 mg
* Drug: Ospemifene 60 mg
* Drug: Placebo
* Drug: Nonhormonal vaginal lubricant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Naturally or surgically postmenopausal Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse) Vaginal pH greater than 5.0 5% or fewer superficial cells in maturation index of vaginal smear Exclusion Criteria: Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology Abnormal Pap smear Uterine bleeding of unknown origin or uterine polyps Current vaginal infection requiring medication

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ospemifene 30 mg/day and nonhormonal vaginal lubricant<br>Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. | Drug: Ospemifene 30 mg<br>* 1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).<br>Drug: Nonhormonal vaginal lubricant<br>* Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.<br>* Other names: K-Y® Brand Jelly;|
| Experimental: Ospemifene 60 mg/day and nonhormonal vaginal lubricant<br>Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. | Drug: Ospemifene 60 mg<br>* 1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).<br>Drug: Nonhormonal vaginal lubricant<br>* Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.<br>* Other names: K-Y® Brand Jelly;|
| Placebo Comparator: Placebo tablets and nonhormonal vaginal lubricant<br>Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. | Drug: Placebo<br>* 1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).<br>Drug: Nonhormonal vaginal lubricant<br>* Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.<br>* Other names: K-Y® Brand Jelly;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness | This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Baseline (Randomization) to Week 12 | 
| Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity | This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Baseline (Randomization) to Week 12 | 
| Mean Change From Baseline in Vaginal pH |  | Baseline (Screening) to Week 12 | 
| Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear |  | Baseline (Screening) to Week 12 | 
| Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear |  | Baseline (Screening) to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Visual Evaluation of the Vagina | Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Baseline (Screening) to Week 12 | 
| Change From Baseline in Severity of VVA Symptoms | This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Baseline (Randomization) to Week 12 | 
| Change From Baseline in Estradiol Levels |  | Baseline (Screening) to Week 12 | 
| Change From Baseline in Follicle Stimulating Hormone Levels |  | Baseline (Screening) to Week 12 | 
| Change From Baseline in Luteinizing Hormone Levels |  | Baseline (Screening) to Week 12 | 
| Change From Baseline in Sex Hormone Binding Globulin Levels |  | Baseline (Screening) to Week 12 | 
| Change From Baseline in Testosterone (Free) Levels |  | Baseline (Screening) to Week 12 | 
| Change From Baseline in Testosterone (Total) Levels |  | Baseline (Screening) to Week 12 | 
| Change From Baseline in Urinary Symptoms |  | Baseline (Randomization) to Week 12 | 

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