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Study to Evaluate the Safety ...

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

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Seasonale (levonorgestrel and ethinyl estradiol)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers