Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women

Wyeth

Status and phase

Withdrawn

Phase 1

Conditions

Contraception

Treatments

Drug: Levonorgestrel/Ethinyl Estradiol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00447863

0858A2-109

Details and patient eligibility

About

Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women aged 18 to 35 years.
Healthy as determined by the investigator on the basis of medical history and screening evaluations.
Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.

Exclusion criteria

Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.