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Steroid hormones for contraception in men

Grimes DA, Lopez LM, Gallo MF, Halpern V, Nanda K, Schulz KF

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Summary

Hormones for contraception (birth control) in men

Researchers have tried to develop contraceptives for men that would be like birth control pills for women. Hormone birth control for men has been hard to achieve. Giving sex hormones to men can lower the sperm produced. However, this approach also lowers the male hormone testosterone in the body, so some testosterone has to be 'added back.' This review looks at the randomized controlled trials of giving hormones to men to prevent their sexual partners from becoming pregnant.

We did a computer search for studies of hormones tested for contraception in men. We also looked at reference lists of articles. We included randomized controlled trials in any language. We wrote to trial authors to find other studies we may have missed.

We found 30 studies. The main focus of the trials was having no sperm in semen. The percent of men who achieved no sperm varied widely. We found a few major differences and list them briefly below:

implants plus injected testosterone worked better than a pill plus testosterone patch;
adding a hormone pill improved the effect of injected testosterone;
a lower dose pill did not work as well as a higher dose when testosterone was put under the skin (implant);
when used with implants, a lower dose of injected testosterone led to no sperm more often than a higher dose;
an injected hormone plus injected testosterone led to no sperm more often when given every 8 weeks versus 12 weeks;
four implants of a male hormone worked better than two implants.

Several trials showed good results for percents with no sperm. Five trials studied testosterone and another hormone. The other hormones were desogestrel, etonogestrel, and levonorgestrel.

Most trials were small pilot studies trying out different hormone treatments. Larger trials with better methods are needed to test good leads in this area.

This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2008 Issue 3, Copyright © 2008 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This record should be cited as: Grimes DA, Lopez LM, Gallo MF, Halpern V, Nanda K, Schulz KF. Steroid hormones for contraception in men. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD004316. DOI: 10.1002/14651858.CD004316.pub3.

This version first published online: July 19. 2004
Last assessed as up-to-date: December 08. 2006

Abstract

Background

Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so 'add-back' therapy is needed.

Objectives

To summarize all randomized controlled trials of male hormonal contraception.

Search strategy

We searched the computerized databases CENTRAL, MEDLINE, EMBASE, POPLINE, and LILACS (each from inception to March 2006) for randomized controlled trials of hormonal contraception in men. We wrote to authors of identified trials to seek unpublished or published trials that we might have missed.

Selection criteria

We included all randomized controlled trials in any language that compared a steroid hormone with another contraceptive. We excluded non-steroidal male contraceptives, such as gossypol. We included both placebo and active-regimen control groups. All trials identified included only healthy men with normal semen analyses.

Data collection and analysis

Azoospermia (absence of spermatozoa on semen examination) was the primary outcome measure. Data were insufficient to examine pregnancy rates and side effects.

Main results

We found 30 trials that met our inclusion criteria. The proportion of men who achieved azoospermia varied widely in reports to date. A few important differences emerged from these trials:

levonorgestrel implants (160 μg per day) combined with injectable testosterone enanthate (TE) were more effective than levonorgestrel 125 µg daily combined with testosterone patches;
levonorgestrel 500 μg daily improved the effectiveness of TE 100 mg injected weekly;
desogestrel 150 μg was less effective than desogestrel 300 μg (with testosterone pellets);
testosterone undecanoate (TU) 500 mg was less likely to produce azoospermia than TU 1000 mg (with levonorgestrel implants);
norethisterone enanthate 200 mg with TU 1000 mg led to more azoospermia when given every 8 weeks versus 12 weeks;
four implants of 7-alpha-methyl-19-nortestosterone (MENT) were more effective than two MENT implants.

Several trials showed promising efficacy in terms of percentages with azoospermia. Three examined desogestrel and testosterone preparations or etonogestrel (metabolite of desogestrel) and testosterone, and two examined levonorgestrel and testosterone.

Authors' conclusions

No male hormonal contraceptive is ready for clinical use. Most trials were small exploratory studies. As a result, their power to detect important differences was limited and their results imprecise. In addition, the definition of oligozoospermia has been imprecise or inconsistent. To avoid bias, future trials need more attention to the methodological requirements for randomized controlled trials (RCTs). More trials with adequate power would also be helpful.

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