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NCT04143659 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception
A Phase 1 study of Healthy Women and Female Contraception, sponsored by Premier Research.
- Active
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
- 7
- Study locations
NCT04143659: Active Phase 1 study of Healthy Women and Female Contraception, sponsored by Premier Research.
NCT04143659 is a Phase 1 study of Healthy Women and Female Contraception that is active but no longer recruiting, run by Premier Research. The registered enrollment target is 136 participants, above the 30-participant average among 4 other Healthy Women trials with a reported enrollment target (353% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04143659, a Phase 1 study of Healthy Women and Female Contraception, is active but no longer recruiting, sponsored by Premier Research.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of injectable LB administered as an IM or SQ injection at 40 mg, and subsequently at 50mg SQ and then 60 mg SQ depending on the preliminary pharmacokinetic and pharmacodynamic results obtained with 40 mg dosing.
Conditions Studied
Interventions
- BIOLOGICAL levonorgestrel butanoate (LB) injection
Study Locations (7)
California
- University of California, Davis - Davis
Colorado
- Comprehensive Women's Health Center - Denver
Massachusetts
- Boston Medical Center Corporation - Boston
New York
- Columbia University - New York
Oregon
- Oregon Health and Science University - Portland
Utah
- University of Utah - Salt Lake City
Virginia
- Eastern Virginia Medical School - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2020-03-03 |
| Est. Completion | 2026-03-26 |
| Phase | Phase 1 |
What the registry record for NCT04143659 still lists
NCT04143659 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, above the 30-participant average among 4 other Healthy Women trials with a reported enrollment target (353% higher).
The record links to 2 conditions, with Healthy Women appearing as the primary indexed condition, and to 1 intervention - of which levonorgestrel butanoate (LB) injection is the first listed.
NCT04143659 lists 7 locations in 7 states (California, Colorado, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04143659 about?
NCT04143659 is a clinical study titled "A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception". This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of injectable LB administered as an IM or SQ injection at 40 mg, and subsequently at 50mg SQ and then 60 mg SQ depending on the preliminary pharmacokinetic and pharmacodynamic results obtained with 40 mg dosing.
What is the current status of trial NCT04143659?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2020-03-03. Estimated completion is 2026-03-26.
What conditions does trial NCT04143659 study?
This clinical trial studies the following conditions: Healthy Women, Female Contraception.
What interventions are being tested in trial NCT04143659?
The interventions under investigation include: levonorgestrel butanoate (LB) injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT04143659?
This trial is sponsored by Premier Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04143659 being conducted?
This trial has 7 study locations across California, Colorado, Massachusetts, New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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