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

Phase 2

Completed

• Conditions: Atrophy; Vaginal Diseases
• Interventions: Drug: Placebo; Drug: Ospemifene 5 mg; Drug: Ospemifene 15 mg; Drug: Ospemifene 30 mg

• Registration Number: NCT00630539
• Lead Sponsor: Shionogi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Status Verified: 2013-03
• Results First Submitted: 2013-03-19
• Results First Submitted QC: 2013-05-21
• Last Update Submitted: 2013-05-21
• Results First Posted: 2013-06-28
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects on placebo	Placebo	Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks
Subjects on ospemifene 5 mg/day	Ospemifene 5 mg	Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks
Subjects on ospemifene 15 mg/day	Ospemifene 15 mg	Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks
Subjects on ospemifene 30 mg/day	Ospemifene 30 mg	Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Primary Outcome Measures

Name	Time	Method
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
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear	12 weeks

Secondary Outcome Measures

Name	Time	Method
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