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ACTIVE NOT RECRUITING Phase 1

A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception

NCT04143659 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 136 participants
Start Date 2020-03-03
Est. Completion 2026-03-26
Phase Phase 1

Sponsor

Premier Research

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04143659

The ClinicalTrials.gov registry entry for NCT04143659 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Premier Research, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04143659 reports 7 study locations spanning 7 distinct geographic areas — top geographies include California, Colorado, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04143659?

The interventions under investigation include: levonorgestrel butanoate (LB) injection (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04143659?

This trial is sponsored by Premier Research, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial