A Clinical Study to Evaluate the Safety of Ospemifene

Phase 3

Completed

• Conditions: Atrophy; Vaginal Diseases
• Interventions: Drug: Ospemifene 60 mg; Drug: Placebo

• Registration Number: NCT00566982
• Lead Sponsor: Shionogi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-11-30
• Study First Posted: 2007-12-04
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2013-03-19
• Results First Submitted QC: 2013-05-21
• Results First Posted: 2013-06-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 426

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ospemifene 60 mg/day	Ospemifene 60 mg	Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks.
Placebo	Placebo	Placebo will be taken once daily, in the morning, with food for 52 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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