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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00447863
First received: March 13, 2007
Last updated: August 21, 2010
Last verified: August 2010

March 13, 2007
August 21, 2010
August 2007
Not Provided
To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics
To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics.
Complete list of historical versions of study NCT00447863 on ClinicalTrials.gov Archive Site
To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women
To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women.
Not Provided
Not Provided
 
Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Contraception
Drug: Levonorgestrel/Ethinyl Estradiol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
Not Provided
August 2007
Not Provided

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.
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00447863
0858A2-109
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP