Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245921
• Other study ID #: 0858A2-313, 314, 320
• Secondary ID: B3211019, B32110
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2005
• Last updated: February 7, 2013
• Start date: February 2003
• Est. completion date: October 2005

Study information

• Verified date: May 2006
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety and contraceptive efficacy
Secondary	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.