Status:
WITHDRAWN
Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
Lead Sponsor:
Duramed Research
Conditions:
Osteopenia
Eligibility:
FEMALE
12-17 years
Phase:
PHASE3
Brief Summary
This is a randomized, multicenter, placebo-controlled study to evaluate the effects of Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent females who have had the...
Eligibility Criteria
Inclusion
- Not sexually active and agree to remain sexually inactive throughout the course of the study
- First menstrual period at least one year ago
- No menstrual period in the last 6 months
Exclusion
- Undiagnosed abnormal genital bleeding
- Known or suspected pregnancy
- Medical history of any disorder that contraindicates the use of oral contraceptives
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00117260
Start Date
July 1 2005
End Date
August 1 2007
Last Update
August 12 2013
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