A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
NCT ID: NCT00276094
Last Updated: 2013-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
826 participants
INTERVENTIONAL
2006-01-31
2007-12-31
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
DOUBLE
Study Groups
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Ospemifene 30 mg/day and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
Ospemifene 30 mg
1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Nonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Ospemifene 60 mg/day and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
Ospemifene 60 mg
1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Nonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Placebo tablets and nonhormonal vaginal lubricant
Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.
Placebo
1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Nonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Interventions
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Ospemifene 30 mg
1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Ospemifene 60 mg
1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Placebo
1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).
Nonhormonal vaginal lubricant
Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Abnormal Pap smear
* Uterine bleeding of unknown origin or uterine polyps
* Current vaginal infection requiring medication
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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Shionogi
Principal Investigators
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Other Identifiers
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15-50310
Identifier Type: -
Identifier Source: org_study_id
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