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NCT00319163 · ClinicalTrials.gov registry record · Phase 1
Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
A Phase 1 study of Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT00319163: Completed Phase 1 study of Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00319163 is a Phase 1 study of Healthy that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 26 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00319163, a Phase 1 study of Healthy, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG levonorgestrel/ethinyl estradiol
Study Locations (1)
Florida
- - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-05 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
What the finished NCT00319163 record still lists
NCT00319163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which levonorgestrel/ethinyl estradiol is the first listed.
NCT00319163 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00319163 about?
NCT00319163 is a clinical study titled "Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women". 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.
What is the current status of trial NCT00319163?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2006-05. Estimated completion is 2006-11.
What conditions does trial NCT00319163 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00319163?
The interventions under investigation include: levonorgestrel/ethinyl estradiol (DRUG).
Who is sponsoring clinical trial NCT00319163?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00319163 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00319163's enrollment target sits among peer trials
26 760th of 1090 higher than 314 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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