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Intervention Review

Steroid hormones for contraception in men

  1. David A Grimes1,*,
  2. Laureen M Lopez1,
  3. Maria F Gallo2,
  4. Vera Halpern1,
  5. Kavita Nanda1,
  6. Kenneth F Schulz3

Editorial Group: Cochrane Fertility Regulation Group

Published Online: 20 JAN 2010

Assessed as up-to-date: 19 MAR 2009

DOI: 10.1002/14651858.CD004316.pub3

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Additional Information

How to Cite

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.

Author Information

  1. 1

    Family Health International, Behavioral and Biomedical Research, Research Triangle Park, North Carolina, USA

  2. 2

    Centers for Disease Control and Prevention, Division of Reproductive Health, Atlanta, Georgia, USA

  3. 3

    Family Health International, Quantitative Sciences, Research Triangle Park, North Carolina, USA

*David A Grimes, Behavioral and Biomedical Research, Family Health International, PO Box 13950, Research Triangle Park, North Carolina, NC 27709, USA. dgrimes@fhi.org.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 20 JAN 2010

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

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 (RCTs) of male hormonal contraception.

Search methods

We searched the computerized databases CENTRAL, MEDLINE, EMBASE, POPLINE, and LILACS, as well as ClinicalTrials.gov and ICTRP. We wrote to authors of identified trials to seek additional unpublished or published trials.

Selection criteria

We included all RCTs 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.

Data collection and analysis

The primary outcome measure was the absence of spermatozoa on semen examination, often called azoospermia. Data were insufficient to examine pregnancy rates and side effects.

Main results

We found 33 trials that met our inclusion criteria. The proportion of men who reportedly achieved azoospermia or had no detectable sperm varied widely. A few important differences emerged: 1) levonorgestrel implants (160 μg daily) combined with injectable testosterone enanthate (TE) were more effective than levonorgestrel 125 µg daily combined with testosterone patches; 2) levonorgestrel 500 μg daily improved the effectiveness of TE 100 mg injected weekly; 3) levonorgestrel 250 μg daily improved the effectiveness of testosterone undecanoate (TU) 1000 mg injection plus TU 500 mg injected at 6 and 12 weeks; 4) desogestrel 150 μg was less effective than desogestrel 300 μg (with testosterone pellets); 5) TU 500 mg was less likely to produce azoospermia than TU 1000 mg (with levonorgestrel implants); 6) norethisterone enanthate 200 mg with TU 1000 mg led to more azoospermia when given every 8 weeks versus 12 weeks; 7) four implants of 7-alpha-methyl-19-nortestosterone (MENT) were more effective than two MENT implants. No meta-analysis was conducted due to intervention differences.

Several trials showed promising efficacy in percentages with azoospermia. Three examined desogestrel and testosterone preparations or etonogestrel 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. Their power to detect important differences was limited and their results imprecise. In addition, assessment of azoospermia can vary by sensitivity of the method used. Future trials need more attention to the methodological requirements for RCTs. More trials with adequate power would also be helpful.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

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 33 studies. The main focus of the trials was having no sperm found in semen. The percent of men who achieved no sperm varied widely. We found a few major differences and list them as follows: 1) implants plus injected testosterone worked better than a pill plus testosterone patch; 2) adding a hormone pill improved the effect of testosterone injected weekly; 3) a hormone pill also improved the effect of a testosterone injection with more injections at 6 and 12 weeks; 4) a lower dose pill did not work as well as a higher dose when testosterone was put under the skin (implant); 5) when used with implants, a lower dose of injected testosterone led to no sperm more often than a higher dose; 6) an injected hormone plus injected testosterone led to no sperm more often when given every 8 weeks versus 12 weeks; 7) 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.

No hormonal birth control for men is ready for general use. 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.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

使用類固醇荷爾蒙於男性避孕

男性的荷爾蒙避孕法一直是被逃避的目標。於男性使用性類固醇會作用在腦下垂體與下視丘，造成停止製造精蟲。但是這種方式也會減少睪固酮的製造，因此需要將睪固酮�添加回去�。

目標

總結所有關於男性荷爾蒙避孕法的隨機對照試驗。

搜尋策略

我們搜尋了電腦化的資料庫，包括 CENTRAL、MEDLINE、EMBASE、POPLINE 及 LILACS(從開始登記到 2006 年3月)關於男性荷爾蒙避孕法的隨機對照試驗。我們寫信給確認的試驗的作者，以取得未發表或是已發表但被我們錯過的試驗。

選擇標準

我們總括了任何語言中類固醇與其他避孕方式比較的隨機對照組的試驗。排除使用例如 gossypol 等非類固醇類男性避孕藥。對照組包含安慰劑以及有效成份的配方。所有的試驗只包括精液分析正常的健康男性。

資料收集與分析

以無精子(精液檢查沒有精蟲)為主要的結果標準。資料不足以檢查懷孕率及副作用。

主要結論

我們搜尋到 30 個符合納入標準的試驗。目前達到無精子的男性比例，依不同的報告差異很大。一些重要的差異出現在這些試驗中： levonorgestrel 植入劑 (每日160微克)配合 testosterone enanthate (TE)注射比 levonorgestrel 每日125微克配合睪固酮貼片有效。 levonorgestrel 每日500微克增加了 每週注射 TE 100毫克的效用。 desogestrel 150微克較 desogestrel 300微克 (加上睪固酮藥丸) 無效。 testosterone undecanoate (TU) 500毫克 較 TU 1000毫克(加上 levonorgestrel 植入劑)不易產生無精蟲。 norethisterone enanthate 200毫克加上 TU 1000毫克每八週使用比每十二週使用更有效。植入四個 7alphamethyl−19nortestosterone (MENT)比兩個有效。 一些試驗顯示在產生無精蟲方面有顯著的效率。其中有三個檢驗 desogestrel 與睪固酮製劑或 etonogestrel(desogestrel 的代謝物)加上睪固酮。另兩個試驗則檢驗 levonorgestrel 與睪固酮。

作者結論

沒有臨床可以使用的男性荷爾蒙類避孕藥。絕大部份的試驗都是小型的探索型研究。因此他們偵測重大差異的能力有限且結果不準確。此外，少精蟲的定義不準確或不穩定。為避免偏差，未來的試驗需要更注意隨機對照試驗方法學上的需求。更多擁有足夠效力的試驗也將有幫助。

翻譯人

本摘要由臺灣大學附設醫院陳俊葦翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

男性荷爾蒙類避孕藥(生育控制)的研究者試圖發展男性專用的類似女性節育丸。男性荷爾蒙節育難以達成，為男性投予性荷爾蒙可以降低精蟲製造，然而也會降低體內睪固酮，所以睪固酮需要被�添加回去�。這篇回顧注目於男性投予荷爾蒙來避免性伴侶懷孕的隨機對照試驗。我們利用電腦搜尋男性避孕藥的荷爾蒙測試，也包括文章的參考文獻列表。任何語言的隨機對照試驗都被採用。我們寫信給試驗的作者搜尋被我們錯失的研究。藉此找到了30個研究。這些試驗的重點在於精液中檢查不出精蟲。達到無精蟲的男性比例差異很大。我們找出一些主要的差異並簡單列於下： ‧ 植入劑加上睪固酮注射比藥丸加上睪固酮貼片有效 ‧ 加入荷爾蒙藥丸增加注射睪固酮的效用 ‧ 當睪固酮植入皮下時，低劑量的藥丸不如高劑量有效 ‧ 當使用植入劑時，低劑量的睪固酮注射比高劑量更常達到無精蟲 ‧ 每8週荷爾蒙注射加上睪固酮注射比每12週注射更常達到無精蟲 ‧ 使用4個男性荷爾蒙植入劑比2個有效 一些試驗顯示達成無精蟲的比例效果很好。5個試驗研究睪固酮與其他荷爾蒙，desogestrel、etonogestrel 與 levonorgestrel。大部分的試驗是為了測試不同荷爾蒙療法的小型先驅研究。這領域還需要較大型且較佳研究方法的試驗來測試好的結論。

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