Atrophy Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | February 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shionogi | Hormos Medical, QuatRx Pharmaceuticals |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 12 weeks | Yes | |
Primary | Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of the Vaginal Smear | 12 weeks | Yes | |
Primary | Mean Change From Baseline in Vaginal pH | 12 weeks | Yes | |
Secondary | Visual Evaluation of Vagina (by Gynecological Examination) | Screening & Week 12 | Yes | |
Secondary | Mean Change From Baseline in Vaginal pH | Week 4 | Yes | |
Secondary | Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index | Week 4 | Yes | |
Secondary | Mean Change From Baseline in Estradiol Levels | Week 12 | Yes | |
Secondary | Mean Change From Baseline in Luteinizing Hormone Levels | Week 12 | Yes | |
Secondary | Mean Change From Baseline in Follicle Stimulating Hormone Levels | Week 12 | Yes | |
Secondary | Mean Change From Baseline in Sex Hormone Binding Globulin Levels | Week 12 | Yes | |
Secondary | Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index | Week 4 | Yes |
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