Evaluating a new injectable contraceptive for women
Official title: A STUDY TO EVALUATE THE PK AND PD OF IM OR SQ INJECTIONS OF LEVONORGESTREL BUTANOATE (LB) FOR FEMALE CONTRACEPTION
Funded at Health Decisions, INC. · NIH-11251139 · Data updated 2026-11-12
This study is testing a new long-lasting birth control shot called levonorgestrel butanoate, which is made for women, especially those who are overweight and may have a higher risk of blood clots, to see how well it works and how it moves through the body, while offering a safer and easier option than taking a pill every day.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Health Decisions, INC. NIH-funded |
| Lab location | 1 site (Morrisville, United States) |
| Project start | May 25, 2023 |
| Project end | April 21, 2025 |
| Funding year | 2025 |
| Award (this year) | $875,641 |
| NIH project number | 75N94019D00004-P00007-759402300002-1 |
| Project ID | NIH-11251139 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are women of childbearing age, particularly those who are obese and seeking estrogen-free contraceptive options.
✕Less likely to help
Patients who are not seeking contraception or those who do not have concerns related to obesity may not benefit from this research.
What this research studies
This research investigates a new long-acting injectable contraceptive called levonorgestrel butanoate (LB), designed specifically for women, particularly those who are obese and at risk for venous thromboembolism (VTE). The study aims to assess the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the effects of the drug) of LB when administered via intramuscular or subcutaneous injections. By providing an estrogen-free option, this contraceptive aims to reduce the risk of VTE while offering a more convenient alternative to daily oral contraceptives. Participants will be monitored for adherence and effectiveness, contributing to the development of safer contraceptive methods.
Why it matters
Potential benefit: If successful, this research could provide a safer and more effective contraceptive option for women, especially those who are obese.
How similar studies have gone: Previous research has shown success with other long-acting contraceptive methods, but this specific injectable formulation is a novel approach.
Where this research is happening
-
Health Decisions, INC.
Morrisville, United States Active
Researchers
- Principal investigator: Dart, Clint — Health Decisions, INC.
- Study coordinator: Dart, Clint
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Evaluating a new injectable contraceptive for women
This study is testing a new long-lasting birth control shot called levonorgestrel butanoate, especially for women who are overweight and at risk for blood clots, to see if it works well and is safe without the added hormones found in other methods.
-
Evaluating a new injectable contraceptive for women
This study is testing a new long-lasting birth control shot called levonorgestrel butanoate, especially for women who are obese and may be at risk for blood clots, to see if it can be a safer and easier option without the hormones found in many other contraceptives.
-
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.