drugset / Trial / NCT00932321
Study of Safety and Efficacy of an Oral Contraceptive
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.
Timeline
- Start
- 2004-01
- Primary completion
- 2004-11
- Completion
- 2004-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Norethindrone | Unknown | 1 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 20 ug | Oral |
Indications
No indication recorded.