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

Shionogi126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

126

Conditions

Atrophy Vaginal Diseases

Interventions

PlaceboDRUG

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).

Ospemifene 5 mgDRUG

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).

Ospemifene 15 mgDRUG

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).

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

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

Time frame: 12 weeks

Mean Change From Baseline in Vaginal pH

Time frame: 12 weeks

Secondary Outcomes

Visual Evaluation of Vagina (by Gynecological Examination)

Time frame: Screening & Week 12

Mean Change From Baseline in Vaginal pH

Time frame: Week 4

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

Time frame: Week 4

Mean Change From Baseline in Estradiol Levels

Time frame: Week 12

Mean Change From Baseline in Luteinizing Hormone Levels

Time frame: Week 12

Mean Change From Baseline in Follicle Stimulating Hormone Levels

Time frame: Week 12

Mean Change From Baseline in Sex Hormone Binding Globulin Levels

Time frame: Week 12

Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index

Time frame: Week 4

Data from ClinicalTrials.gov

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