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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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 Intervention Phase
Contraception
 Drug: Levonorgestrel/Ethinyl Estradiol
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics

Secondary Outcome Measures:
  • To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women

Study Start Date: August 2007
Estimated Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447863

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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00447863     History of Changes
Other Study ID Numbers: 0858A2-109
Study First Received: March 13, 2007
Last Updated: August 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Estrogens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 22, 2013