Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

Oral Contraceptive Clinical Trial

Official title:

A Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 Mg and Ethinyl Estradiol 20 Mg in a Continuous 28-Day Regimen for Oral Contraception Versus a Cyclic 21-Day Regimen Oral Contraceptive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248963
• Other study ID #: 0858A2-315
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2005
• Last updated: May 17, 2006
• Est. completion date: October 2004

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: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception.

• Women must be sexually active and at risk for becoming pregnant.

• Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period preceding study visit 1.

Exclusion Criteria:

• High blood pressure

• Age greater then 34 and smoking more than 15 cigarettes per day.

• Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Oral Contraceptive

Intervention

Drug:
• Levonorgestrel 90 mg and 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 the contraceptive efficacy of an OC containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen
Secondary	To evaluate the effects on vaginal bleeding profile, hemostatic balance, lipid, carbohydrate, bone metabolism measures, hemoglobin levels, discontinuation rates, compliance with respect to pill taking, subject satisfaction