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OpenTrials
Completed

NCT Number: NCT00245921

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.

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Key information

Conditions

Contraception

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy women aged 18 to 49 years
  • Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1
  • Must be sexually active and at risk for becoming pregnant.

Exclusion criteria

  • Planned use of any other form of birth control other than the test article.
  • Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.
  • High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).

Treatment and study plan

Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg

Drug

Primary outcomes

  1. To evaluate safety and contraceptive efficacy

Secondary outcomes

  1. To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg in a Continuous Daily Regimen for Oral Contraception

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 28, 2005
Registry last updated
Feb 8, 2013

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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