Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
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|ClinicalTrials.gov Identifier: NCT00248963|
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : May 19, 2006
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|Condition or disease||Intervention/treatment||Phase|
|Oral Contraceptive||Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Completion Date :||October 2004|
- 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
- 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
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|Ages Eligible for Study:||18 Years to 49 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248963
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|
|Other Study ID Numbers:||
|First Posted:||November 4, 2005 Key Record Dates|
|Last Update Posted:||May 19, 2006|
|Last Verified:||May 2006|
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Hormonal