Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females

Summary

The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.

Timeline

Start

2008-05

Primary completion

2008-10

Completion

2008-10

Outcome

Mixed primary results

registry MEAN NGM/25mcg EE: 1.9 (Standard Deviation 3.14) Days NCT00745901 ↗

registry analysis (superiority or other test); NGM/25mcg EE vs DRSP/20mcg EE; p = 0.9698; Wilcoxon (Mann-Whitney) NCT00745901 ↗

registry MEAN NGM/25mcg EE: 4.6 (Standard Deviation 5.33) Days NCT00745901 ↗

registry MEAN DRSP/20mcg EE: 6.1 (Standard Deviation 6.07) Days NCT00745901 ↗

registry analysis (superiority or other test); NGM/25mcg EE vs DRSP/20mcg EE; p = 0.0031; Wilcoxon (Mann-Whitney) NCT00745901 ↗

Publications

• Results Kaunitz AM, Burkman RT, Fisher AC, LaGuardia KD. Cycle control with a 21-day compared with a 24-day oral contraceptive pill: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1205-1212. doi: 10.1097/AOG.0b013e3181beab47.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Drospirenone/ethinyl estradiol	Unknown	20 ug	Oral
Subject	Norgestimate/ethinyl estradiol	Unknown	25 ug	Oral

Indications

No indication recorded.