A Clinical Study to Evaluate the Safety of Ospemifene

Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo

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 Overview

• Status: Completed
• Conditions: Atrophy; Vaginal Diseases
• Intervention / Treatment: Drug: Ospemifene 60 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 426
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ospemifene 60 mg/day; Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks.	Drug: Ospemifene 60 mg; 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.; Other Names: Osphena®
Placebo Comparator: Placebo; Placebo will be taken once daily, in the morning, with food for 52 weeks.	Drug: Placebo; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Change From Baseline in Vaginal pH	12 weeks
Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear	12 weeks
Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Estradiol Levels	52 weeks
Change From Baseline in Luteinizing Hormone Levels	52 weeks
Change From Baseline in Follicle Stimulating Hormone Levels	52 weeks
Change From Baseline in Sex Hormone Binding Globulin Levels	52 weeks
Visual Evaluation of the Vagina (Baseline & Week 52)	52 weeks

Collaborators and Investigators

• Sponsor: Shionogi
• Collaborators: Hormos Medical; QuatRx Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: November 30, 2007
• First Submitted That Met QC Criteria: November 30, 2007
• First Posted (Estimate): December 4, 2007

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Menopausal symptoms; Urogenital atrophy; Vulvar and vaginal atrophy in postmenopausal women; Vaginal atrophy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Vaginal Diseases; Atrophy
• Other Study ID Numbers: 15-50718