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Gian Luigi Gigli, M.D.
MATERCARE INTERNATIONAL STATEMENT
ON ‘MALE PILL’ STUDY PUBLISHED OCTOBER, 20161
The authors’ premise is that the development of a safe and effective reversible method of male contraception is still an unmet need. This prospective study began in 2008 and involved 10 centres. It’s aim was to evaluate an injectable male contraceptive.
There were 320 healthy male participants, ranging in age from 18-45 years, and their female partners. None had known fertility problems. Every 8 weeks, the men received intramuscular injections of 200-mg norethisterone enanthate combined with 1000-mg testosterone undecanoate. The main outcomes were suppression of spermatogenesis (sperm production), measured by ejaculate analysis (sperm count), and contraceptive protection, measured by pregnancy rate (number of pregnancies during the study).
The results are summarized:
A total of 1,491 adverse events (complications) were reported by participants, including injection site pain, muscle pain, increased libido and acne. The frequency of mild to moderate mood disorder was relatively high, and there was one death from suicide. Only 100 of 320 recruits continued to participate in the study. Of the 100 continuing users, 96% suppressed their sperm concentration to less than or equal to 1 million/mL within 24 weeks. After ceasing injections, spermatogenesis recovered in 95% within 52 weeks. At 4 years there was one participant whose spermatogenesis had ‘partially recovered’. Four pregnancies occurred and there were 3 live births.
The study was terminated early following the recommendation of an external safety review committee.
The study found a high rate of adverse events and low rate of ongoing participation. Mood disorder and increased libido are likely to have impacted negatively on the affected participant’s spouse or partner. Compared to reversible female hormonal contraception, there was a significant time lag to achieving a contraceptive effect, and recovery took over twice as long. In up to 1/20 participants, a contraceptive effect was not achieved. Monitoring the achievement and reversal of sterility is therefore necessary and can only be done via serial semen analyses. Many men might find this inconvenient and objectionable.
There were no reported cases of venous thromboembolism (VTE). However, the number of continuing users was small. In June 2014, the U.S. Food and Drug Administration required that all approved testosterone products carry a warning about VTE risk2. Since then, the FDA has expanded its testosterone warning to include an increased risk of heart attacks, personality change and infertility3. A study published in BMJ online on Nov 30, 2016, reported that men taking testosterone had a 63% increased risk of VTE which could cause a heart attack, stroke, organ damage or even death4.
Unfortunately, women who use oral hormonal contraception are also at increased risk of depression. A recently published Danish study, involving over 1 million women, found an increased risk for first use of an antidepressant and first diagnosis of depression, among users of different types of hormonal contraception, with the highest rates amongst adolescents5.
Modern Fertility Awareness-Based Methods (FABMS), such as Billings Ovulation Method, Creighton Method System, Sympto-thermal method and Fertility Education and Medical Management) have much to offer couples who seek an effective, affordable method which fairly shares the responsibility of family planning, while not imposing any serious side effects on either member of the couple6,7. In MaterCare’s view, modern FABMs remain the method of choice for family planning.
The male contraceptive study of Behre et al, which was terminated early due to a high rate of adverse events (including one suicide), underlines the importance of recommending safe & efficacious family planning to our patients, such as a modern Fertility Awareness-Based Method.
1. Behre HM, Zitzmann M, Anderson RA, Handelsman DJ, et al. Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men. Journal of Clinical Endocrinology & Metabolism. 2016; 2016-2141. http://press.endocrine.org/doi/abs/10.1210/jc.2016-2141#sthash.vrnfI2Gq.dpuf
4. BMJ 2016; 355 doi: http://dx.doi.org/10.1136/bmj.i5968 (Published 30 November 2016)
Cite this as: BMJ 2016;355:i5968
5. Skovlund CW, Mørch LS, Kessing LV et al. Association of Hormonal Contraception With Depression. JAMA Psychiatry. 2016; 73(11):1154-1162.
6. Turner J. Fertility-awareness practice and education in general practice. Australian Journal of Primary Health, 2016; 22, 375–376. http://dx.doi.org/10.1071/PY16097
7. Smoley B, Robinson C. Natural Family Planning. Am Fam Physician. 2012;15;86(10):924-928.
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