# CCTN-PHARMACOKINETIC / PHARMACODYNAMIC EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION

> **NIH NIH N01** · OREGON HEALTH & SCIENCE UNIVERSITY · 2021 · $160,207

## Abstract

There is a demand for estrogen-free contraception in order to reduce the risk of venous
thromboembolism (VTE), particularly for obese women. A new long-acting 􀁸ormulation of
levonorgestrel butanoate (LB) delivered by injection has been developed. Levonorgestrel (LNG)
has a long history of clinical use in a variety of contraceptives (pills, intrauterine devices, and
implants) and its efficacy and safety are well recognized.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD) has a mission to develop safe and effective contraceptives for women, including obese
women. Obesity is the number one public health issue facing the US population and is an
independent risk for venous thromboembolism (VTE). Therefore, there is a public health need to
develop effective contraception for obese woman that does not increase the risk of VTE. One
Food and Drug Administration (FDA) -approved contraceptive method is the progestin-only pill
(POP) or so-called "mini pill," which is used mainly by lactating women only for several months
and requires strict adherence to taking the POP at the same time every day. A long-acting
injectable form of LB that is estrogen-free will provide a regimen that is easier to follow than a
POP and have a theoretically lower risk of VTE especially for obese women. In order to provide
preliminary evidence that LB could be effective for contraception, a clinical trial will be
conducted in the NICHD Contraceptive Clinical Trials Network (CCTN).
The proposed study will be conducted in women of reproductive age in order to evaluate
pharmacokinetics, the mechanisms of contraceptive efficacy, and safety of this new
contraceptive. The enrolled subjects will receive LB via intramuscular and subcutaneous routes of
injection. The Recruitment will include enrollment of approximately 50% of subjects with BMI
>=32 kg/m2 but less than 40 kg/m2

## Key facts

- **NIH application ID:** 10497858
- **Project number:** 275201300008I-P00001-27500008-1
- **Recipient organization:** OREGON HEALTH & SCIENCE UNIVERSITY
- **Principal Investigator:** JEFFREY JENSEN
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $160,207
- **Award type:** —
- **Project period:** 2018-09-28 → 2023-09-27

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10497858

## Citation

> US National Institutes of Health, RePORTER application 10497858, CCTN-PHARMACOKINETIC / PHARMACODYNAMIC EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION (275201300008I-P00001-27500008-1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10497858. Licensed CC0.

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