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

Sponsor

Duramed Research (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00117260

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jul 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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