Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
NCT00245921
ABOUT THIS STUDY
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- Healthy women aged 18 to 49 years
- Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1
- Must be sexually active and at risk for becoming pregnant.
- Planned use of any other form of birth control other than the test article.
- Depression requiring hospitalization or associated with suicidal ideation within the
last 3 years.
- High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception | |||
Official Title ICMJE | A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg in a Continuous Daily Regimen for Oral Contraception | |||
Brief Summary | To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) | |||
Condition ICMJE | Contraception | |||
Intervention ICMJE | Drug: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Reid RL, Fortier MP, Smith L, Mirkin S, Grubb GS, Constantine GD. Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada. Contraception. 2010 Dec;82(6):497-502. doi: 10.1016/j.contraception.2010.06.002. Epub 2010 Jul 16. | |||
* 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 | 2000 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2005 | |||
Actual Primary Completion Date | October 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 49 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
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 | NCT00245921 | |||
Other Study ID Numbers ICMJE | 0858A2-313, 314, 320 B3211019, B3211020, B3211022 ( Other Identifier: Pfizer ) | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
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 |