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

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00447863
Collaborator
(none)
0
Enrollment

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
  • Drug: Levonorgestrel/Ethinyl Estradiol
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2007
Study Completion Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

  1. To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics []

Secondary Outcome Measures

  1. To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

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.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00447863
Other Study ID Numbers:
  • 0858A2-109
First Posted:
Mar 15, 2007
Last Update Posted:
Aug 20, 2021
Last Verified:
Aug 1, 2021
Additional relevant MeSH terms:
Levonorgestrel
Ethinyl Estradiol
Estradiol

Study Results

No Results Posted as of Aug 20, 2021