The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa

NCT00320567 ↗

Phase 2 Completed 123 enrolled McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the effect of norgestimate/ethinyl estradiol on lumbar spine (L1-L4) and total hip bone mineral density (BMD) in pediatric subjects with anorexia nervosa.

Timeline

Start: —
Primary completion: —
Completion: 2004-04

Outcome

Missed primary endpoint

paper the mean increase in LS BMD in the NGM/EE group compared with placebo was no longer significant (.026 g/cm2 vs. .019 g/cm2, p = .244). PMID 17116511 ↗

paper treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD. PMID 17116511 ↗

Publications

Results Strokosch GR, Friedman AJ, Wu SC, Kamin M. Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in adolescent females with anorexia nervosa: a double-blind, placebo-controlled study. J Adolesc Health. 2006 Dec;39(6):819-27. doi: 10.1016/j.jadohealth.2006.09.010.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Norgestimate	Small molecule	0.18 mg	Oral
Subject	Norgestimate	Small molecule	0.215 mg	Oral
Subject	Norgestimate	Small molecule	0.25 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.035 mg	Oral