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OpenTrials
Completed

NCT Number: NCT00319163

Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE.

Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Miami, Florida, 33126, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women 18 - 35 years of age
  • Non-smokers

Exclusion criteria

  • History of thromboembolic disease
  • Prior adverse experiences with oral contraceptives

Treatment and study plan

Levonorgestrel/Ethinyl estradiol

Drug

Primary outcomes

  1. Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound

Secondary outcomes

  1. Additional safety--clinical labs

  2. electrocardiograms (ECGs)

  3. vital signs

  4. and adverse event recording over 4 days following administration of each formulation (LNG/EE)

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Open-label, Single-dose, Randomized, 2-period, Crossover, Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Apr 27, 2006
Registry last updated
Aug 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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