Dataset Information

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

ABSTRACT:

Background

11?-methyl-19-nortestosterone (11?-MNT) is a modified testosterone (T) with androgenic and progestational activity. A single oral dose of the prodrug, 11?-MNT dodecylcarbonate (11?-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 11?-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 11?-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. 11?-MNTDC resulted in a dose-related increase in serum 11?-MNTDC and 11?-MNT concentrations sustained over 24 hours. Administration of 11?-MNTDC resulted in a marked suppression of serum gonadotropins, T, calculated free T, estradiol, and SHBG over the treatment period (P?ConclusionDaily oral 11?-MNTDC for 28 days in healthy men markedly suppressed serum gonadotropin and T concentrations without serious adverse effects. These results warrant further evaluation of 11?-MNTDC as a potential male oral contraceptive.

SUBMITTER: Yuen F

PROVIDER: S-EPMC7049261 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Yuen Fiona F Thirumalai Arthi A Pham Cindy C Swerdloff Ronald S RS Anawalt Bradley D BD Liu Peter Y PY Amory John K JK Bremner William J WJ Dart Clint C Wu Hongsheng H Hull Laura L Blithe Diana L DL Long Jill J Wang Christina C Page Stephanie T ST

The Journal of clinical endocrinology and metabolism 20200301 3

<h4>Background</h4>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.<h4>Methods</h4>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 tolerabi ...[more]

PMID: 31976519

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