drugset / Trial / NCT00996580
A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
NaSingle-groupOpen-labelPrevention
Summary
This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
Timeline
- Start
- 2009-10
- Primary completion
- 2011-09
- Completion
- 2011-09
Publications
- Results Poindexter A, Reape KZ, Hait H. Efficacy and safety of a 28-day oral contraceptive with 7 days of low-dose estrogen in place of placebo. Contraception. 2008 Aug;78(2):113-9. doi: 10.1016/j.contraception.2008.04.001. Epub 2008 Jun 2.
- Portman DJ, Kaunitz AM, Howard B, Weiss H, Hsieh J, Ricciotti N. Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive. Contraception. 2014 Apr;89(4):299-306. doi: 10.1016/j.contraception.2014.01.013. Epub 2014 Jan 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levonorgestrel | Small molecule | 150 ug | Oral |
| Subject | ethinyl estradiol | Small molecule | 20 ug | Oral |
Indications
No indication recorded.