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

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel/Ethinyl Estradiol (Drug)

Phase: Phase 1

Status: Withdrawn

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

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: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Additional Information

Starting date: August 2007
Last updated: August 21, 2010

Page last updated: August 23, 2015

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