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Study Evaluating Levonorgestrel and Ethinyl Estradiol in 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: Oral Contraceptive

Intervention: Levonorgestrel 90 mg and 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 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.

Clinical Details

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

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

Primary outcome: 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 outcome: 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

Eligibility

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

Criteria:

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.

Locations and Contacts

Additional Information


Last updated: May 17, 2006

Page last updated: August 23, 2015

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