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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Recruitment Status : Withdrawn (Sponsor decision)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
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Description
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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 Design
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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

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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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

Eligibility Criteria
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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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Duramed Research, Inc
ClinicalTrials.gov Identifier: NCT00117260     History of Changes
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
Estradiol
Ethinyl Estradiol
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined