Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Educational/Counseling/Training
    • Masking: None (Open Label)

Interventions

  • Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wyeth is now a wholly owned subsidiary of Pfizer
  • Overall Official(s)
    • Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer

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