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

Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A Phase II Dose Ranging, 12-Week, Randomized , Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 5 mg, 15 mg and 30 mg Daily Doses With Placebo

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 Overview

• Status: Completed
• Conditions: Atrophy; Vaginal Diseases
• Intervention / Treatment: Drug: Placebo; Drug: Ospemifene 5 mg; Drug: Ospemifene 15 mg; Drug: Ospemifene 30 mg

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

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
• 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Subjects on placebo; Subjects will self-administer 1 placebo tablet daily (in the morning with food) for 12 weeks	Drug: Placebo; 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).
Experimental: Subjects on ospemifene 5 mg/day; Subjects will self-administer 1 ospemifene 5 mg tablet daily (in the morning with food) for 12 weeks	Drug: Ospemifene 5 mg; 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).
Experimental: Subjects on ospemifene 15 mg/day; Subjects will self-administer 1 ospemifene 15 mg tablet daily (in the morning with food) for 12 weeks	Drug: Ospemifene 15 mg; 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).
Experimental: Subjects on ospemifene 30 mg/day; Subjects will self-administer 1 ospemifene 30 mg tablet daily (in the morning with food) for 12 weeks	Drug: Ospemifene 30 mg; 1 tablet of ospemifene 30 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual Evaluation of Vagina (by Gynecological Examination)	Screening & Week 12
Mean Change From Baseline in Vaginal pH	Week 4
Mean Change From Baseline in Percentage of Superficial Cells in the Maturation Index	Week 4
Mean Change From Baseline in Estradiol Levels	Week 12
Mean Change From Baseline in Luteinizing Hormone Levels	Week 12
Mean Change From Baseline in Follicle Stimulating Hormone Levels	Week 12
Mean Change From Baseline in Sex Hormone Binding Globulin Levels	Week 12
Mean Change From Baseline in Percentage of Parabasal Cells in the Maturation Index	Week 4

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: February 28, 2008
• First Submitted That Met QC Criteria: March 6, 2008
• First Posted (Estimate): March 7, 2008

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: May 21, 2013
• Last Verified: March 1, 2013

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; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Tamoxifen
• Other Study ID Numbers: 15-50717

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No