Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density
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ClinicalTrials.gov Identifier: NCT00117260 |
Recruitment Status :
Withdrawn
(Sponsor decision)
First Posted : July 6, 2005
Last Update Posted : August 12, 2013
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Sponsor:
Duramed Research
Information provided by:
Teva Pharmaceutical Industries
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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 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 or disease | Intervention/treatment | Phase |
---|---|---|
Osteopenia | Drug: Seasonale (levonorgestrel and ethinyl estradiol) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 Start Date : | July 2005 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | August 2007 |
Resource links provided by the National Library of Medicine

Primary Outcome Measures :
- Mean percent change in the lumbar spine bone mineral density at month 12
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine

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Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
No Contacts or Locations Provided
Responsible Party: | Duramed Research, Inc |
ClinicalTrials.gov Identifier: | NCT00117260 |
Other Study ID Numbers: |
SEA-305 |
First Posted: | July 6, 2005 Key Record Dates |
Last Update Posted: | August 12, 2013 |
Last Verified: | August 2013 |
Keywords provided by Teva Pharmaceutical Industries:
osteopenia bone mineral density amenorrhea adolescents |
Additional relevant MeSH terms:
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Levonorgestrel Ethinyl estradiol, levonorgestrel drug combination Estradiol Ethinyl Estradiol Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptives, Oral, Combined |