drugset / Trial / NCT00651469
Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.
Timeline
- Start
- 2003-01
- Primary completion
- —
- Completion
- 2004-07
Publications
- Results Koltun W, Maloney JM, Marr J, Kunz M. Treatment of moderate acne vulgaris using a combined oral contraceptive containing ethinylestradiol 20 mug plus drospirenone 3mg administered in a 24/4 regimen: a pooled analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):171-5. doi: 10.1016/j.ejogrb.2010.12.027. Epub 2011 Feb 2.
- Maloney JM, Dietze P Jr, Watson D, Niknian M, Lee-Rugh S, Sampson-Landers C, Korner P. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):773-81. doi: 10.1097/AOG.0b013e318187e1c5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | drospirenone | Unknown | 3 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 0.02 mg | Oral |