Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

Shionogi919 enrolled

Overview

The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

919

Conditions

Atrophy Vaginal Diseases

Interventions

Ospemifene 60 mgDRUG

60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

PlaceboDRUG

oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Naturally or surgically menopausal * Moderate or severe symptoms of vaginal atrophy * 5% or fewer superficial cells in maturation index of vaginal smear * Vaginal pH greater than 5.0 * Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization Exclusion Criteria: * Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids * Current vaginal infection requiring medication * Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g. uterine or vaginal prolapse of Grade 2 or higher) * Previous participation in any other ospemifene study

Outcomes

Primary Outcomes

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)

Time frame: 12 weeks

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)

Time frame: 12 weeks

Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)

Time frame: 12 weeks

Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)

Time frame: 12 weeks

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)

Time frame: 12 weeks

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)

Time frame: 12 weeks

Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)

Time frame: 12 weeks

Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)

Time frame: 12 weeks

Secondary Outcomes

Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)

Time frame: 4 weeks

Data from ClinicalTrials.gov

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