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

Duramed Research

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Osteopenia

Interventions

Seasonale (levonorgestrel and ethinyl estradiol)DRUG

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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