A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
Phase 3
Completed
- Conditions
- AtrophyVaginal Diseases
- Interventions
- Registration Number
- NCT00276094
- Lead Sponsor
- Shionogi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 826
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ospemifene 30 mg/day and nonhormonal vaginal lubricant Ospemifene 30 mg Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. Ospemifene 60 mg/day and nonhormonal vaginal lubricant Ospemifene 60 mg Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. Ospemifene 30 mg/day and nonhormonal vaginal lubricant Nonhormonal vaginal lubricant Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. Placebo tablets and nonhormonal vaginal lubricant Placebo Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. Placebo tablets and nonhormonal vaginal lubricant Nonhormonal vaginal lubricant Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2. Ospemifene 60 mg/day and nonhormonal vaginal lubricant Nonhormonal vaginal lubricant Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear Baseline (Screening) to Week 12 Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear Baseline (Screening) to Week 12 Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness Baseline (Randomization) to Week 12 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
Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity Baseline (Randomization) to Week 12 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
Mean Change From Baseline in Vaginal pH Baseline (Screening) to Week 12
- Secondary Outcome Measures
Name Time Method Change From Baseline in Visual Evaluation of the Vagina Baseline (Screening) to Week 12 Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Change From Baseline in Severity of VVA Symptoms Baseline (Randomization) to Week 12 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
Change From Baseline in Estradiol Levels Baseline (Screening) to Week 12 Change From Baseline in Follicle Stimulating Hormone Levels Baseline (Screening) to Week 12 Change From Baseline in Luteinizing Hormone Levels Baseline (Screening) to Week 12 Change From Baseline in Sex Hormone Binding Globulin Levels Baseline (Screening) to Week 12 Change From Baseline in Testosterone (Free) Levels Baseline (Screening) to Week 12 Change From Baseline in Testosterone (Total) Levels Baseline (Screening) to Week 12 Change From Baseline in Urinary Symptoms Baseline (Randomization) to Week 12