# Examining the Androgenic and Progestational Effects of Novel Androgens for Male Contraception

> **NIH NIH F32** · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · 2021 · $38,571

## Abstract

Clinical trials of male hormonal contraception (MHC) use an androgen-progestin combination to suppress
gonadotropins and spermatogenesis. Selective androgen receptor modulators (SARMs) that possess both
androgenic and progestational activity are an attractive approach to MHC and are being developed by NICHD. I
participated in recent NICHD supported Phase 1 studies on the oral SARMs, 11β-methyl-nortestosterone
dodecylcarbonate (11β-MNTDC) and dimethandrolone undecanoate (DMAU). While analyzing data from these
studies, I noticed weight gain and significant changes in HDL, similar to changes that occurred in MHC trials of
men receiving testosterone-progestin combinations. Our long-term objective is to develop a novel SARM with
specific characteristics to maximize beneficial and minimize adverse effects on metabolic parameters. The
premise of this study is to comprehensively assess metabolic effects of SARMs and androgen-progestin
combinations in order to guide selection choice of which compound(s) is most beneficial to long-term health. The
study aims are: AIM 1: Compare the impact of SARMs and testosterone-progestin combinations on weight,
insulin resistance, and lipids in healthy men. This will be assessed retrospectively using residual sera from prior
trials. We hypothesize that certain progestins will contribute to insulin resistance and dyslipidemia compared to
androgens alone. AIM 2: Prospectively compare the effects of DMAU with and without oral levonorgestrel (an
androgenic progestin) on body composition and metabolic parameters. In an ongoing 12-week placebo-
controlled study, as a corollary to the main study we will compare the impact of DMAU alone or with
levonorgestrel (LNG) on changes in lean mass. We hypothesize that DMAU will increase lean and decrease fat
mass. Addition of LNG, an androgenic progestin, to DMAU could decrease lean mass and increase insulin
resistance and dyslipidemia compared to DMAU alone.
This clinical study will directly provide training on and experience with: 1) hands-on laboratory-based research
experience using immunoassays and liquid chromatography/tandem mass spectrometry; 2) measurement of
body composition using bioelectrical impedance and DXA scanning; 3) clinical research training including
regulatory approval processes, data management, IND amendments, and grant writing; and 4) power
calculations and statistical analysis of data across multiple trials. This study will produce preliminary data to
support a planned K23 application to NICHD. Collectively, this study and my proposed training plan will
significantly advance my career in translational research and assist in my goal of becoming an independent
investigator in male contraception with a focus on metabolic effects.

## Key facts

- **NIH application ID:** 10406801
- **Project number:** 3F32HD097932-02S1
- **Recipient organization:** LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
- **Principal Investigator:** Fiona N Yuen
- **Activity code:** F32 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $38,571
- **Award type:** 3
- **Project period:** 2021-09-04 → 2022-03-03

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10406801

## Citation

> US National Institutes of Health, RePORTER application 10406801, Examining the Androgenic and Progestational Effects of Novel Androgens for Male Contraception (3F32HD097932-02S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10406801. Licensed CC0.

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