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

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

Sponsors

Lead Sponsor: Duramed Research

Source 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.

Overall Status Withdrawn
Start Date 2005-07-01
Completion Date 2007-08-01
Primary Completion Date 2007-07-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean percent change in the lumbar spine bone mineral density at month 12
Secondary Outcome
Measure Time Frame
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
Condition
Intervention

Intervention Type: Drug

Intervention Name: Seasonale (levonorgestrel and ethinyl estradiol)

Eligibility

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

Gender:

Female

Minimum Age:

12 Years

Maximum Age:

17 Years

Healthy Volunteers:

No

Verification Date

2013-08-01

Responsible Party

Name Title: Duramed Research, Inc

Keywords
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double

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