A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives

Teva Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Ovarian Follicle

Follicle Development

Follicle Size

Follicle Count

Oral Contraceptive

Treatments

Drug: 28-day levonorgestrel oral contraceptive

Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol

Drug: 28-day drospirenone oral contraceptive

Study type

Interventional

Funder types

Industry

Identifiers

NCT01291004

DSG-OI-101

Details and patient eligibility

About

This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.

Enrollment

206 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Premenopausal, non-pregnant, non-lactating women age 18-35 years old
Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
Regular spontaneous menstrual cycle
Others as dictated by Food and Drug Administration (FDA)-approved protocol

Exclusion criteria

Any condition which contraindicates the use of combination oral contraceptives
Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders
Migraine headaches with focal, neurological symptoms
Others as dictated by FDA-approved protocol