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Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: To evaluate safety and contraceptive efficacy

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Female.

Criteria:

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).

Locations and Contacts

Additional Information

Starting date: February 2003
Last updated: February 7, 2013

Page last updated: August 23, 2015

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