Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
NCT00319163
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Adult Trials: 18+ Years
- Women 18 - 35 years of age
- Non-smokers
- History of thromboembolic disease
- Prior adverse experiences with oral contraceptives
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women | |||
| Official Title ICMJE | An Open-label, Single-dose, Randomized, 2-period, Crossover, Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women | |||
| Brief Summary | Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE. Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
| Condition ICMJE | Healthy | |||
| Intervention ICMJE | Drug: levonorgestrel/ethinyl estradiol | |||
| 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 | 26 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | November 2006 | |||
| Actual Primary Completion Date | November 2006 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 35 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00319163 | |||
| Other Study ID Numbers ICMJE | 0858A2-108 | |||
| 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 | August 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||