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Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00117260
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : July 6, 2005
Last Update Posted : August 12, 2013
Information provided by:
Teva Pharmaceutical Industries

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

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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 :
  1. Mean percent change in the lumbar spine bone mineral density at month 12

Secondary Outcome Measures :
  1. Interim and 24 month mean percent change in lumbar spine bone mineral density
  2. Mean percent change in the proximal femur (hip) bone mineral density
  3. Mean percent change in total body bone mineral density
  4. Mean change in biochemical markers of bone resorption and bone formation
  5. 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

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
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Responsible Party: Duramed Research, Inc 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:
bone mineral density
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol
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