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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00319163
The ClinicalTrials.gov registry entry for NCT00319163 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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