Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

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: NCT00245921
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : February 8, 2013
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official 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
Study Start Date : February 2003
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Primary Outcome Measures :
  1. To evaluate safety and contraceptive efficacy

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

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): NCT00245921

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00245921     History of Changes
Other Study ID Numbers: 0858A2-313, 314, 320
B3211019, B3211020, B3211022 ( Other Identifier: Pfizer )
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: May 2006

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Ethinyl estradiol, levonorgestrel drug combination
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined