Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women
Information source: Wyeth
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Levonorgestrel/Ethinyl Estradiol (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
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.
Clinical Details
Official title: An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg in 2 Dosage Forms With Different Dissolution Characteristics in Healthy, Cycling Women
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics
Secondary outcome: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Miami, Florida 33126, United States
Additional Information
Starting date: August 2007
Ending date: August 2007
Last updated: June 19, 2007
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