A Clinical Study to Evaluate the Safety of Ospemifene

Shionogi426 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

426

Conditions

Atrophy Vaginal Diseases

Interventions

Ospemifene 60 mgDRUG

60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.

PlaceboDRUG

Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

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

Time frame: 12 weeks

Mean Change From Baseline in Vaginal pH

Time frame: 12 weeks

Secondary Outcomes

Change From Baseline in Estradiol Levels

Time frame: 52 weeks

Change From Baseline in Luteinizing Hormone Levels

Time frame: 52 weeks

Change From Baseline in Follicle Stimulating Hormone Levels

Time frame: 52 weeks

Change From Baseline in Sex Hormone Binding Globulin Levels

Time frame: 52 weeks

Visual Evaluation of the Vagina (Baseline & Week 52)

Time frame: 52 weeks

Data from ClinicalTrials.gov

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