A Phase 2 interventional study of norgestimate/ethinyl estradiol in Osteoporosis, sponsored by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.. Completed. Open to female participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2011-07-01.
Sponsored by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · Phase 2, Interventional, and Treatment
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.
Although oral contraceptives are prescribed in an effort to prevent bone loss in adolescents with anorexia nervosa, there have been no previous definitive placebo-controlled studies evaluating the effectiveness of oral contraceptive treatment on bone mineral density in pediatric females with anorexia nervosa. This is a randomized (patients are assigned different treatments based on chance), multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled study to evaluate the bone mineral density in pediatric patients with anorexia nervosa following treatment with norgestimate/ethinyl estradiol or placebo for 13 consecutive 28-day cycles. Norgestimate/Ethinyl Estradiol is packaged in a 28-day blistercard. Each tablet contains the following:
a) Days 1-7 0.180 mg norgestimate/0.035 mg ethinyl estradiol b) Days 8-14 0.215 mg norgestimate/0.035 mg ethinyl estradiol c) Days 15-21 0.250 mg norgestimate/0.035 mg ethinyl estradiol d) Days 22-28 inactive tablets;One tablet is to be taken once daily by mouth. After 28 days, the next cycle is started the following day without interruption. Color-matched placebo tablets are identically pack
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 123 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
norgestimate/ethinyl estradiol
Drug: norgestimate/ethinyl estradiol
The change in total lumbar spine (L1-L4) bone mineral density from baseline to Cycle 6 (Visit 6).
The percent change in total lumbar spine BMD from baseline to Cycle 6. The change and percent change in total lumbar spine BMD from baseline to Cycle 13. The change and percent change in total hip BMD from baseline to Cycle 6 and Cycle 13.
No study locations are listed for this record.
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.