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

Last updated on November 13, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Contraception
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-35 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00447863
Pfizer
Withdrawn
Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women

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Descriptive Information
Brief Title  ICMJE Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women
Official Title  ICMJE 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
Brief SummaryLevonorgestrel/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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Contraception
Intervention  ICMJE Drug: Levonorgestrel/Ethinyl Estradiol
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE August 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location CountriesUnited States
 
Administrative Information
NCT Number  ICMJE NCT00447863
Other Study ID Numbers  ICMJE 0858A2-109
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateAugust 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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