Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics []
Secondary Outcome Measures
- To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women aged 18 to 35 years.
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Healthy as determined by the investigator on the basis of medical history and screening evaluations.
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Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.
Exclusion Criteria:
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Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
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Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
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Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0858A2-109