Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill

Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men : A Prototype Male Pill / Arthi Thirumalai, Jonas Ceponis, John K. Amory, Ronald Swerdloff, Vijaya Surampudi, Peter Y. Liu, William J. Bremner, Eric Harvey, Diana L. Blithe, Min S. Lee, Laura Hull, Christina Wang, Stephanie T. Page. - (The Journal of Clinical Endocrinology & Metabolism 104 (2019) 2 (February) ; p. 423–432).
- PMID: 30252061
- PMCID: PMC6306388
- DOI: 10.1210/jc.2018-01452


Abstract

Context: Dimethandrolone (DMA) has androgenic and progestational activity. Single oral doses of DMA undecanoate (DMAU) were well tolerated and reversibly suppressed serum LH and testosterone (T) in men.

Objective: Assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral DMAU.

Design: Double-blind, randomized, placebo-controlled study.

Setting: Two academic medical centers.

Participants: Healthy men (18 to 50 years).

Interventions: One hundred men received DMAU [0, 100, 200, or 400 mg, formulated in castor oil/benzyl benzoate (C) or powder (P)] for 28 days. Subjects underwent 24-hour PK sampling on days 1 and 28 and twice weekly ambulatory visits throughout treatment.

Main outcome measures: Primary outcomes were safety and tolerability parameters (vitals, laboratory data, mood, and sexual function scores) and adverse events. Secondary outcomes were drug PK profiles and PD effects (serum LH, FSH, and sex hormones).

Results: Eighty-two subjects completed the study and were included in the analysis. There were no serious adverse events. No clinically significant changes developed in safety laboratory parameters. A significant dose effect was seen for weight, hematocrit, high-density lipoprotein cholesterol, corrected QT interval, and sexual desire. Serum 24-hour average concentrations of DMAU and DMA showed dose-related increases (P < 0.001). All six subjects in the P400 group and 12 of 13 subjects in the C400 group achieved marked suppression of LH and FSH (<1.0 IU/L) and serum T (<50 ng/dL).

Conclusions: Daily oral administration of DMAU for 28 days in healthy men is well tolerated. Doses of ≥200 mg markedly suppress serum T, LH, and FSH. These results support further testing of DMAU as a male contraceptive.

Original document

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Science
Study
Date
24 September 2018
People
Amory, John K.
Blithe, Diana L.
Bremner, William J.
Ceponis, Jonas
Harvey, Eric
Hull, Laura
Lee, Min S.
Liu, Peter Y.
Page, Stephanie T.
Surampudi, Vijaya
Swerdloff, Ronald S.
Thirumalai, Arthi
Wang, Christina
Country
United States of America
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English
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lietuvos sveikatos mokslų universitetas (LSMU) - Lithuanian University of Health Sciences
University of California (UC)
University of California, Los Angeles (UCLA)
University of Washington (UW)
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Fertility
Legitimate Medical Treatment
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30 March 2020
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8 April 2020
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