Status:
COMPLETED
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
Lead Sponsor:
Shionogi
Collaborating Sponsors:
Hormos Medical
QuatRx Pharmaceuticals
Conditions:
Atrophy
Vaginal Diseases
Eligibility:
FEMALE
40-80 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
826 Patients enrolled
Trial Details
Trial ID
NCT00276094
Start Date
January 1 2006
End Date
December 1 2007
Last Update
June 28 2013
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