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Bone Density |
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Clinical Trial: Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
This study is not yet open for patient recruitment.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Osteopenia | Drug: Seasonale (levonorgestrel and ethinyl estradiol) | Phase III |
MedlinePlus related topics: Bone Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Further Study Details:
Primary Outcomes: Mean percent change in the lumbar spine bone mineral density at month 12
Secondary Outcomes: Interim and 24 month mean percent change in lumbar spine bone mineral density; Mean 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
Expected Total Enrollment: 100
Secondary Outcomes: Interim and 24 month mean percent change in lumbar spine bone mineral density; Mean 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
Expected Total Enrollment: 100
Study start: July 2005; Expected completion: September 2007
Last follow-up: August 2007; Data entry closure: September 2007
Eligibility
Ages Eligible for Study: 12 Years - 16 Years, Genders Eligible for Study: 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:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00117260
Arlene Santhouse, PharmD 610-747-2679 asanthouse@barrlabs.com
Duawn Campellone 610-747-2679 dcampellone@barrlabs.com
Duawn Campellone 610-747-2679 dcampellone@barrlabs.com
Kentucky
Duramed Investigational Site, Louisville, Kentucky, 40492, United States
Ohio
Duramed Investigational Site, Cleveland, Ohio, 44109, United States
Rhode Island
Duramed Investigational Site, Providence, Rhode Island, 02903, United States
More Information
Study ID Numbers: SEA-305
Record last reviewed: June 2005
Last Updated: July 18, 2005
Record first received: July 5, 2005
ClinicalTrials.gov Identifier: NCT00117260
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: June 2005
Last Updated: July 18, 2005
Record first received: July 5, 2005
ClinicalTrials.gov Identifier: NCT00117260
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
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