Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2007-10-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ospemifene 60 mg/day
Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks.
Ospemifene 60 mg
60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.
Placebo
Placebo will be taken once daily, in the morning, with food for 52 weeks.
Placebo
Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)
Interventions
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Ospemifene 60 mg
60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food.
Placebo
Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intact uterus
* Vaginal pH greater than 5.0
* 5% or fewer superficial cells in maturation index of vaginal smear
Exclusion Criteria
* 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
40 Years
80 Years
FEMALE
No
Sponsors
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Hormos Medical
INDUSTRY
QuatRx Pharmaceuticals
INDUSTRY
Shionogi
INDUSTRY
Responsible Party
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Other Identifiers
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15-50718
Identifier Type: -
Identifier Source: org_study_id
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