Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception
NCT00248963
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Adult Trials: 18+ Years
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Educational/Counseling/Training | |||
| Condition ICMJE | Oral Contraceptive | |||
| Intervention ICMJE | Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 600 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | October 2004 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 49 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00248963 | |||
| Other Study ID Numbers ICMJE | 0858A2-315 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | May 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||