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Daily Oral Administration of the Novel Androgen 11β-MNTDC Markedly Suppresses Serum Gonadotropins in Healthy Men

The journal of clinical endocrinology and metabolism, 2020-03, Vol.105 (3), p.e835-e847 [Peer Reviewed Journal]

Endocrine Society 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2020 ;Copyright © Oxford University Press 2015 ;Endocrine Society 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. ;Endocrine Society 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com ;ISSN: 0021-972X ;EISSN: 1945-7197 ;DOI: 10.1210/clinem/dgaa032 ;PMID: 31976519

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Title:
Daily Oral Administration of the Novel Androgen 11β-MNTDC Markedly Suppresses Serum Gonadotropins in Healthy Men
Author: Yuen, Fiona ; Thirumalai, Arthi ; Pham, Cindy ; Swerdloff, Ronald S ; Anawalt, Bradley D ; Liu, Peter Y ; Amory, John K ; Bremner, William J ; Dart, Clint ; Wu, Hongsheng ; Hull, Laura ; Blithe, Diana L ; Long, Jill ; Wang, Christina ; Page, Stephanie T
Subjects: Acne ; Administration, Oral ; Adolescent ; Adult ; Cholesterol ; Contraception - methods ; Contraceptive Agents, Male - administration & dosage ; Contraceptive Agents, Male - adverse effects ; Contraceptive Agents, Male - pharmacokinetics ; Double-Blind Method ; Down-Regulation - drug effects ; Drug Administration Schedule ; Estradiol ; Estrenes - administration & dosage ; Estrenes - adverse effects ; Estrenes - pharmacokinetics ; Gonadotropins ; Gonadotropins - blood ; Headache ; Healthy Volunteers ; Hematocrit ; Hemoglobin ; Humans ; Male ; Middle Aged ; Mood ; Online Only ; Oral administration ; Pharmacodynamics ; Pharmacokinetics ; Pituitary (anterior) ; Sex hormones ; Side effects ; Testosterone ; Young Adult
Is Part Of: The journal of clinical endocrinology and metabolism, 2020-03, Vol.105 (3), p.e835-e847
Description: Abstract Background 11β-methyl-19-nortestosterone (11β-MNT) is a modified testosterone (T) with androgenic and progestational activity. A single oral dose of the prodrug, 11β-MNT dodecylcarbonate (11β-MNTDC), was well tolerated in healthy men. Methods We conducted a randomized, double-blind study at 2 academic medical centers. 42 healthy men (18–50 years) were randomized to receive oral placebo or 11β-MNTDC, 200 or 400 mg daily, for 28 consecutive days. Primary outcome (safety and tolerability) measures were assessed twice per week. Subjects underwent serial blood sampling over 24 hours on days 1 and 28 to assess secondary outcomes: pharmacokinetics (serum drug concentrations); pharmacodynamics of 11β-MNTDC (serum sex steroids and gonadotropins); and mood and sexual function (via validated questionnaires). Results There were no serious adverse events. No participants discontinued because of an adverse event or laboratory test abnormality. 11β-MNTDC resulted in a dose-related increase in serum 11β-MNTDC and 11β-MNT concentrations sustained over 24 hours. Administration of 11β-MNTDC resulted in a marked suppression of serum gonadotropins, T, calculated free T, estradiol, and SHBG over the treatment period (P < 0.01). Adverse effects that may be related to 11β-MNTDC included weight gain, acne, headaches, fatigue, and mild mood changes, with 5 men reporting decreased libido and 3 decreased erectile/ejaculatory function. Serum low-density lipoprotein cholesterol, weight (~2 kg), hematocrit, and hemoglobin increased and serum high-density lipoprotein cholesterol decreased in both 11β-MNTDC groups. Conclusion Daily oral 11β-MNTDC for 28 days in healthy men markedly suppressed serum gonadotropin and T concentrations without serious adverse effects. These results warrant further evaluation of 11β-MNTDC as a potential male oral contraceptive.
Publisher: US: Oxford University Press
Language: English
Identifier: ISSN: 0021-972X
EISSN: 1945-7197
DOI: 10.1210/clinem/dgaa032
PMID: 31976519
Source: Geneva Foundation Free Medical Journals at publisher websites
MEDLINE
Alma/SFX Local Collection

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Daily Oral Administration of the Novel Androgen 11β-MNTDC Markedly Suppresses Serum Gonadotropins in Healthy Men

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