drugset / Trial / NCT00391807
Study of Safety and Efficacy of an Oral Contraceptive
Non-randomizedSingle-groupOpen-labelPrevention
Summary
This is a non-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; and to assess the safety and tolerability of the product.
Timeline
- Start
- 2006-11
- Primary completion
- 2008-08
- Completion
- 2008-09
Publications
- Nakajima ST, Pappadakis J, Archer DF. Body mass index does not affect the efficacy or bleeding profile during use of an ultra-low-dose combined oral contraceptive. Contraception. 2016 Jan;93(1):52-7. doi: 10.1016/j.contraception.2015.09.013. Epub 2015 Sep 26.
- Archer DF, Nakajima ST, Sawyer AT, Wentworth J, Trupin S, Koltun WD, Gilbert RD, Ellman H. Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms as an ultra low-dose oral contraceptive. Obstet Gynecol. 2013 Sep;122(3):601-7. doi: 10.1097/AOG.0b013e3182a1741c.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Norethindrone | Unknown | 1 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 10 ug | Oral |
Indications
No indication recorded.