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

Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630539
• Other study ID #: 15-50717
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2008
• Last updated: May 21, 2013
• Start date: August 2007
• Est. completion date: February 2008

Study information

• Verified date: March 2013
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Institutional Review BoardUnited States: Food and Drug AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPDenmark: Danish Dataprotection AgencyFinland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Vaginal Diseases

Intervention

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).
• 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).
• 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).
• 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).

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