Combined Nestorone-testosterone Gel Suppresses Serum Gonadotropins to Concentrations Associated with Effective Hormonal Contraception in Men

Overview

Journal Andrology

Specialties Reproductive Medicine
Urology

Date 2019 Apr 11

PMID 30969032

Citations 17

Authors

B D Anawalt

M Y Roth

J Ceponis

V Surampudi

J K Amory

R S Swerdloff

P Y Liu

C Dart

W J Bremner

R Sitruk-Ware

N Kumar

D L Blithe

S T Page

C Wang

Affiliations

Soon will be listed here.

Abstract

Background: Novel male-based contraceptives are needed to broaden family planning choices. A progestin, Nestorone (Nes) gel, plus a testosterone (T) gel suppresses sperm concentrations to levels associated with effective contraception in normal men. However, administration of two gels on different parts of the body daily is impractical.

Objective: Compare the effectiveness of daily application of a single, combined 8.3 mg Nes-62.5 mg T gel (Nes-T) vs. 62.7 mg T gel to suppress serum FSH and LH concentrations to ≤1.0 IU/L (a threshold associated with suppression of sperm concentrations to ≤1 million and effective contraception) and to compare the pharmacokinetics of serum Nes and T concentrations between the gel groups.

Design: We conducted a 28-day, double-blind, controlled trial of 44 healthy men randomized to daily Nes-T or T gel with measurement of hormones at baseline, treatment, and recovery and during 24-h pharmacokinetic studies on days 1 and 28 of treatment.

Results: Of the subjects who met pre-defined inclusion criteria, 84% of the Nes-T group suppressed serum gonadotropin concentrations to ≤1.0 IU/L at days 21-28 vs. 16.7% in the T group (p < 0.001). On day 1, Nes concentrations rose significantly above baseline by 2 h and continued to rise up to 24 h after Nes-T gel application. Nes concentrations were not detectable in the T group. Serum total T concentrations rose and were significantly higher in the T gel group compared to the Nes-T group at 24 h on day 1 and days 11, 14, and 21 (p < 0.01). There were no serious adverse events in either group. About 80% of the subjects reported satisfaction with both gels.

Conclusion: Daily Nes-T gel effectively and safely suppresses serum gonadotropins and is acceptable to most men. It should be studied further in efficacy trials of hormonal male contraception.

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