Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)

Phase 3 Completed 110 enrolled Organon and Co

RandomizedParallel-groupOpen-labelPrevention

Summary

The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD).

Timeline

Start: 2006-09
Primary completion: 2009-06
Completion: 2009-06

Outcome

Missed primary endpoint

registry analysis (unspecified test); NOMAC-E2 vs LNG-EE; p = 0.19; Difference of adjusted means -0.078 (95% CI -0.198 to 0.041); ANCOVA; NCT00511342 ↗

registry analysis (unspecified test); NOMAC-E2 vs LNG-EE; p = 0.57; Difference of adjusted means -0.030 (95% CI -0.136 to 0.075); ANCOVA; NCT00511342 ↗

paper Differences between treatment groups were not significant (p= 0.19 and p= 0.57, respectively). PMID 22762147 ↗

Publications

Results Sordal T, Grob P, Verhoeven C. Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17beta-estradiol in comparison to levonorgestrel/ethinylestradiol. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1279-85. doi: 10.1111/j.1600-0412.2012.01498.x. Epub 2012 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	1.5 mg	—
Comparator	Levonorgestrel	Small molecule	0.15 mg	Oral
Subject	Nomegestrol Acetate	Small molecule	2.5 mg	Oral
Comparator	ethinyl estradiol	Small molecule	0.03 mg	—

Indications

No indication recorded.