WithdrawnPhase 3

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

Stopped: Sponsor decision

0Started 2005-07

Plain-language 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.

Who can participate

Age range12 Years – 17 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT00117260

SponsorDuramed Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-07

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