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

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...

Date First Received: June 30, 2005

Last Updated: November 20, 2007

Verified by: Duramed Research, November 2007

Clinical Trial Phase: Phase 3 | Start Date: July 2005

Overall Status: Withdrawn

Estimated Enrollment: 100

Brief Summary

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”

Condition Keyword(s):

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: Seasonale (levonorgestrel and ethinyl estradiol)

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean percent change in the lumbar spine bone mineral density at month 12

Secondary 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

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Duramed Research

Additional Information

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00117260

Study ID Number: SEA-305

ClinicalTrials.gov Identifier: NCT00117260

Health Authority: United States: Food and Drug Administration

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