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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrophy Vaginal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Subjects on placebo

Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Subjects on ospemifene 5 mg/day

Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks

Group Type EXPERIMENTAL

Ospemifene 5 mg

Intervention Type DRUG

1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Subjects on ospemifene 15 mg/day

Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks

Group Type EXPERIMENTAL

Ospemifene 15 mg

Intervention Type DRUG

1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Subjects on ospemifene 30 mg/day

Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks

Group Type EXPERIMENTAL

Ospemifene 30 mg

Intervention Type DRUG

1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Interventions

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Placebo

1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Intervention Type DRUG

Ospemifene 5 mg

1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Intervention Type DRUG

Ospemifene 15 mg

1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Intervention Type DRUG

Ospemifene 30 mg

1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No