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NCT02173808 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study to Evaluate the PK and PD of a Single Injection of Levonorgestrel Butanoate for Female Contraception
A Phase 1 study of Contraceptive Usage, sponsored by Premier Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02173808: Completed Phase 1 study of Contraceptive Usage, sponsored by Premier Research.
NCT02173808 is a Phase 1 study of Contraceptive Usage that has completed, run by Premier Research. The registered enrollment target is 16 participants, below the 627-participant average among 11 other Contraceptive Usage trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02173808, a Phase 1 study of Contraceptive Usage, has completed, sponsored by Premier Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a single 20 mg dose of levonorgestrel butanoate (LB).
Primary Outcome
PK profile will be assessed in terms of the pharmacodynamics profile that correlates with the goal of reversible female contraception. For each subject and for the low and high BMI groups, the primary endpoint will be the time to return of ovulation based on two consecutive serum progesterone \>3 ng/L or a single progesterone \>10 ng/L.
Conditions Studied
Interventions
- BIOLOGICAL levonorgestrel butanoate
Study Locations (1)
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT02173808 record still lists
NCT02173808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 627-participant average among 11 other Contraceptive Usage trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Contraceptive Usage appearing as the primary indexed condition, and to 1 intervention - of which levonorgestrel butanoate is the first listed.
NCT02173808 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT02173808 about?
NCT02173808 is a clinical study titled "A Phase I Study to Evaluate the PK and PD of a Single Injection of Levonorgestrel Butanoate for Female Contraception". To evaluate the levonorgestrel (LNG) pharmacokinetic (PK) profile following injection of a single 20 mg dose of levonorgestrel butanoate (LB).
What is the current status of trial NCT02173808?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2011-05. Estimated completion is 2012-06.
What conditions does trial NCT02173808 study?
This clinical trial studies the following conditions: Contraceptive Usage.
What interventions are being tested in trial NCT02173808?
The interventions under investigation include: levonorgestrel butanoate (BIOLOGICAL).
Who is sponsoring clinical trial NCT02173808?
This trial is sponsored by Premier Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02173808 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02173808's enrollment target sits among peer trials
16 12th of 11 the lowest of 11 other Contraceptive Usage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraceptive Usage 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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