Trial intelligence / Profile preview

Seasonale for Low Bone Mineral Density in Adolescent Females with Secondary Amenorrhea

NCT00117260Phase 3Withdrawn

Sponsor
Duramed Research
Start
Jul 2005
Primary completion
Jul 2007
Modality
Small Molecules
01

Overview

Phase 3, randomised, double-blind trial in osteopenia comparing Seasonale with Placebo (2 arms). Primary endpoint: Mean percent change in the lumbar spine bone mineral density at month 12. Planned start Jul 2005; status: withdrawn.

02

Drugs

ethinylestradiol + levonorgestrel
03

Conditions

osteopenia

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