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

COMPLETEDPHASE3

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

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

NCT00276094•Shionogi

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

40 - 80 years

Sex

FEMALE

Healthy Volunteers

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

Key Dates

Start Date

January 1, 2006

Completion Date

December 1, 2007

Last Updated

June 28, 2013

Enrollment

826

ACTUAL participants

Conditions

AtrophyVaginal Diseases

Interventions

Ospemifene 30 mg

DRUG

Ospemifene 60 mg

DRUG

Placebo

DRUG

Nonhormonal vaginal lubricant

DRUG

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NCT06900374

Vaginal DrynessBreast Cancer+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

[18F]F-DOPA Imaging in Patients With Autonomic Failure

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