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

Shionogi826 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

826

Conditions

Atrophy Vaginal Diseases

Interventions

Ospemifene 30 mgDRUG

1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).

Ospemifene 60 mgDRUG

1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).

PlaceboDRUG

1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness

This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

Time frame: Baseline (Randomization) to Week 12

Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity

This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

Time frame: Baseline (Randomization) to Week 12

Mean Change From Baseline in Vaginal pH

Time frame: Baseline (Screening) to Week 12

Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear

Time frame: Baseline (Screening) to Week 12

Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear

Time frame: Baseline (Screening) to Week 12

Secondary Outcomes

Change From Baseline in Visual Evaluation of the Vagina

Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

Time frame: Baseline (Screening) to Week 12

Change From Baseline in Severity of VVA Symptoms

This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe

Time frame: Baseline (Randomization) to Week 12

Data from ClinicalTrials.gov

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