Overview

Study of Safety and Efficacy of an Oral Contraceptive

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Warner Chilcott
Treatments:
Contraceptive Agents
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Norethindrone
Norethindrone Acetate
Polyestradiol phosphate
Criteria
Inclusion Criteria:

- Healthy Women

- Age 18-45

- At risk for pregnancy

- History of regular cycles

Exclusion Criteria:

- Contraindications for use of hormonal contraception

- Conditions which affect the absorption or metabolism of steroid hormones

- BMI > 35