Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
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
1 other identifier
interventional
600
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 2, 2005
CompletedFirst Posted
Study publicly available on registry
November 4, 2005
CompletedMay 19, 2006
May 1, 2006
November 2, 2005
May 17, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- ECT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 2005
First Posted
November 4, 2005
Study Completion
October 1, 2004
Last Updated
May 19, 2006
Record last verified: 2006-05