A Clinical Study to Evaluate the Safety of Ospemifene

Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566982
• Other study ID #: 15-50718
• Status: Completed
• Phase: Phase 3
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: April 2018
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Diseases

Intervention

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.
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shionogi	Hormos Medical, QuatRx Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear		12 weeks
Primary	Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear		12 weeks
Primary	Mean Change From Baseline in Vaginal pH		12 weeks
Secondary	Change From Baseline in Estradiol Levels		52 weeks
Secondary	Change From Baseline in Luteinizing Hormone Levels		52 weeks
Secondary	Change From Baseline in Follicle Stimulating Hormone Levels		52 weeks
Secondary	Change From Baseline in Sex Hormone Binding Globulin Levels		52 weeks
Secondary	Visual Evaluation of the Vagina (Baseline & Week 52)		52 weeks