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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteopenia

Intervention: Seasonale (levonorgestrel and ethinyl estradiol) (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Duramed Research

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Mean percent change in the lumbar spine bone mineral density at month 12

Secondary outcome:

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

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Female.

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

Locations and Contacts

Additional Information

Starting date: July 2005
Last updated: August 8, 2013

Page last updated: August 23, 2015

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