Status:
COMPLETED
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
Lead Sponsor:
Shionogi
Collaborating Sponsors:
Hormos Medical
QuatRx Pharmaceuticals
Conditions:
Atrophy
Vaginal Diseases
Eligibility:
FEMALE
40-80 years
Phase:
PHASE2
Brief 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 belo...
Eligibility Criteria
Inclusion
- Naturally or surgically menopausal
- Vaginal pH greater than 5.0
- 5% or fewer superficial cells in maturation index of vaginal smear
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00630539
Start Date
August 1 2007
End Date
February 1 2008
Last Update
June 28 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.