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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447863
Recruitment Status : Withdrawn
First Posted : March 15, 2007
Last Update Posted : August 24, 2010
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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
Contraception Drug: Levonorgestrel/Ethinyl Estradiol Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 2007
Study Completion Date : August 2007

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447863

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Layout table for additonal information Identifier: NCT00447863    
Other Study ID Numbers: 0858A2-109
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: August 2010
Additional relevant MeSH terms:
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Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral