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

Phase 1

Withdrawn

• Conditions: Contraception

• Registration Number: NCT00447863
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-14
• Study First Posted: 2007-03-15
• Study Start: 2007-08
• Study Completion: 2007-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics

Secondary Outcome Measures

Name	Time	Method
To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women