Status:
COMPLETED
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
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 the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
919 Patients enrolled
Trial Details
Trial ID
NCT00729469
Start Date
July 1 2008
End Date
August 1 2009
Last Update
May 18 2018
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