Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
- Registration Number
- NCT00729469
- Lead Sponsor
- Shionogi
- Brief Summary
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 919
Inclusion Criteria
- Naturally or surgically menopausal
- Moderate or severe symptoms of vaginal atrophy
- 5% or fewer superficial cells in maturation index of vaginal smear
- Vaginal pH greater than 5.0
- Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization
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Exclusion Criteria
- Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
- Current vaginal infection requiring medication
- Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.
uterine or vaginal prolapse of Grade 2 or higher)
- Previous participation in any other ospemifene study
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ospemifene 60 mg/day and K-Y® lubricant Ospemifene 60 mg Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. Placebo and K-Y® lubricant Placebo Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata) 12 weeks Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) 12 weeks Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata) 12 weeks Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata) 12 weeks Change From Baseline to Week 12 in Vaginal pH (Dryness Strata) 12 weeks Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) 12 weeks Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata) 12 weeks Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata) 12 weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata) 4 weeks Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata) 4 weeks Change From Baseline to Week 4 in Vaginal pH (Dryness Strata) 4 weeks Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata) 4 weeks Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata) 4 weeks Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata) 4 weeks Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata) 4 weeks Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata) 4 weeks