drugset / Trial / NCT00413062
Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)
RandomizedParallel-groupOpen-labelPrevention
Summary
The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
Timeline
- Start
- 2006-06
- Primary completion
- 2008-08
- Completion
- 2008-08
Publications
- Witjes H, Creinin MD, Sundstrom-Poromaa I, Martin Nguyen A, Korver T. Comparative analysis of the effects of nomegestrol acetate/17 beta-estradiol and drospirenone/ethinylestradiol on premenstrual and menstrual symptoms and dysmenorrhea. Eur J Contracept Reprod Health Care. 2015;20(4):296-307. doi: 10.3109/13625187.2015.1016154. Epub 2015 Feb 25.
- Westhoff C, Kaunitz AM, Korver T, Sommer W, Bahamondes L, Darney P, Verhoeven C. Efficacy, safety, and tolerability of a monophasic oral contraceptive containing nomegestrol acetate and 17beta-estradiol: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):989-99. doi: 10.1097/AOG.0b013e318250c3a0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 1.5 mg | Oral |
| Subject | Nomegestrol Acetate | Small molecule | 2.5 mg | Oral |
| Comparator | drospirenone | Unknown | 3 mg | Oral |
| Comparator | ethinyl estradiol | Small molecule | 30 ug | Oral |
Indications
No indication recorded.