A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy 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 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276094
• Other study ID #: 15-50310
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2006
• Last updated: May 21, 2013
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: March 2013
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 826
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Naturally or surgically postmenopausal

• Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)

• Vaginal pH greater than 5.0

• 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

• Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology

• Abnormal Pap smear

• Uterine bleeding of unknown origin or uterine polyps

• Current vaginal infection requiring medication

Study Design

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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Diseases

Intervention

Drug:
• Ospemifene 30 mg
1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
• Ospemifene 60 mg
1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
• Placebo
1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
• Nonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.

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 the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness	This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe	Baseline (Randomization) to Week 12	No
Primary	Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity	This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe	Baseline (Randomization) to Week 12	No
Primary	Mean Change From Baseline in Vaginal pH		Baseline (Screening) to Week 12	No
Primary	Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear		Baseline (Screening) to Week 12	No
Primary	Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear		Baseline (Screening) to Week 12	No
Secondary	Change From Baseline in Visual Evaluation of the Vagina	Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe	Baseline (Screening) to Week 12	No
Secondary	Change From Baseline in Severity of VVA Symptoms	This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe	Baseline (Randomization) to Week 12	No
Secondary	Change From Baseline in Estradiol Levels		Baseline (Screening) to Week 12	No
Secondary	Change From Baseline in Follicle Stimulating Hormone Levels		Baseline (Screening) to Week 12	No
Secondary	Change From Baseline in Luteinizing Hormone Levels		Baseline (Screening) to Week 12	No
Secondary	Change From Baseline in Sex Hormone Binding Globulin Levels		Baseline (Screening) to Week 12	No
Secondary	Change From Baseline in Testosterone (Free) Levels		Baseline (Screening) to Week 12	No
Secondary	Change From Baseline in Testosterone (Total) Levels		Baseline (Screening) to Week 12	No
Secondary	Change From Baseline in Urinary Symptoms		Baseline (Randomization) to Week 12	No