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

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...

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Bibliographic Details
Published in:The journal of clinical endocrinology and metabolism 2020-03, Vol.105 (3), p.e835-e847
Main Authors: 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
Format: Article
Language:English
Subjects:
17β-Estradiol
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
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
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Summary: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 
ISSN:0021-972X
1945-7197
DOI:10.1210/clinem/dgaa032