Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
Information source: Duramed Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteopenia
Intervention: Seasonale (levonorgestrel and ethinyl estradiol) (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Duramed Research
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 their menstrual period but now have secondary amenorrhea and also have
osteopenia. The duration of the study for each patient will be approximately two years.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a 91-Day Extended-Cycle Combination Oral Contraceptive (Seasonale) for the Treatment of Low Bone Mineral Density in Adolescent Females With Secondary Amenorrhea and Osteopenia
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Mean percent change in the lumbar spine bone mineral density at month 12
Secondary outcome: Interim and 24 month mean percent change in lumbar spine bone mineral densityMean percent change in the proximal femur (hip) bone mineral density Mean percent change in total body bone mineral density Mean change in biochemical markers of bone resorption and bone formation Change in body weight
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- Undiagnosed abnormal genital bleeding
- Known or suspected pregnancy
- Medical history of any disorder that contraindicates the use of oral contraceptives
Locations and Contacts
Duramed Investigational Site, Louisville, Kentucky 40492, United States
Duramed Investigational Site, Cleveland, Ohio 44109, United States
Duramed Investigational Site, Providence, Rhode Island 02903, United States
Additional Information
Starting date: July 2005
Ending date: August 2007
Last updated: November 20, 2007
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