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Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill.
J Clin Endocrinol Metab 2019; 104(2):423-432JC

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.

Authors+Show Affiliations

Department of Medicine, University of Washington School of Medicine, Seattle, Washington.Los Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California. Institute of Endocrinology, Lithuanian University of Health Sciences, Kaunas, Lithuania.Department of Medicine, University of Washington School of Medicine, Seattle, Washington.Los Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California.University of California, Los Angeles, Los Angeles, California.Los Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California.Department of Medicine, University of Washington School of Medicine, Seattle, Washington.Health Decisions, Durham, North Carolina.National Institutes of Health - National Institute of Child Health and Human Development, Bethesda, Maryland.National Institutes of Health - National Institute of Child Health and Human Development, Bethesda, Maryland.Los Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California.Los Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California.Department of Medicine, University of Washington School of Medicine, Seattle, Washington.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30252061

Citation

Thirumalai, Arthi, et al. "Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: a Prototype Male Pill." The Journal of Clinical Endocrinology and Metabolism, vol. 104, no. 2, 2019, pp. 423-432.
Thirumalai A, Ceponis J, Amory JK, et al. Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill. J Clin Endocrinol Metab. 2019;104(2):423-432.
Thirumalai, A., Ceponis, J., Amory, J. K., Swerdloff, R., Surampudi, V., Liu, P. Y., ... Page, S. T. (2019). Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill. The Journal of Clinical Endocrinology and Metabolism, 104(2), pp. 423-432. doi:10.1210/jc.2018-01452.
Thirumalai A, et al. Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: a Prototype Male Pill. J Clin Endocrinol Metab. 2019 Feb 1;104(2):423-432. PubMed PMID: 30252061.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill. AU - Thirumalai,Arthi, AU - Ceponis,Jonas, AU - Amory,John K, AU - Swerdloff,Ronald, AU - Surampudi,Vijaya, AU - Liu,Peter Y, AU - Bremner,William J, AU - Harvey,Eric, AU - Blithe,Diana L, AU - Lee,Min S, AU - Hull,Laura, AU - Wang,Christina, AU - Page,Stephanie T, PY - 2018/07/03/received PY - 2018/09/16/accepted PY - 2019/09/24/pmc-release PY - 2018/9/27/pubmed PY - 2018/9/27/medline PY - 2018/9/26/entrez SP - 423 EP - 432 JF - The Journal of clinical endocrinology and metabolism JO - J. Clin. Endocrinol. Metab. VL - 104 IS - 2 N2 - 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. SN - 1945-7197 UR - https://www.unboundmedicine.com/medline/citation/30252061/Effects_of_28_Days_of_Oral_Dimethandrolone_Undecanoate_in_Healthy_Men:_A_Prototype_Male_Pill L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2018-01452 DB - PRIME DP - Unbound Medicine ER -