Male Contraceptive Shot

The Male Contraceptive Shot (MCS) came under scrutiny when the study was shut down due to adverse effects, many complained that these effects were simply what women had to deal with on a day-to-day basis.

[I must admit, I originally canned this post as mra-uk posted a far superior article but, following a chat with Mike Buchanan after the Norwich screening of The Red Pill, I have reconsidered. Yes, I understand the Norwich screening of The Red Pill was a wee while ago but, I work ridiculous hours so have been unable to attend to this – which is also why my site has been very quiet for nearly a quarter of a year. I hope my loyal fans understand. I have now since handed in my notice at said place of employment so, all being well, I should be able to resume a more prolific upload schedule.]

The study, titled “Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men”, tested the use of an intramuscular injection of 200-mg norethisterone enanthate combined with 1000-mg testosterone undecanoate, administered every 8 weeks. However, due to adverse effects, the study was halted early. Many took issue with that.

In a video posted onto their FaceBook page (but not their main site), Fusion Media laments how “We have needed male birth control for so long”, then condescendingly derides the 6% of men in the study for suffering adverse effects similar to the female contraceptive. The female contraceptive in question is not specified, obfuscating the juxtaposition they’re attempting to make. This, I assume, is so they can blame a “double-standard”, and imply that it is sexism (aka misogyny) rather than any other cause, that shut down the study. I will, as most people probably did, assume that the female contraceptive in question is The Pill. Another implication of the comparison Fusion attempts to make is that the adverse effects suffered by the men in this study, whilst similar to the adverse effects women suffer, are to the same or similar degree of severity and frequency. These implications will be discussed.



But here comes the real double-standard, the real difference between the sexes, here is a list of readily available contraceptive methods for men and women (I suspect I may have missed some out):

 

Male Options

Female Options

Abstinence Abstinence
Pull Out Condoms
Condoms Female Condoms (Femdoms)
Vasectomy Diaphragm
Cervical Cap
Spermicide
Natural Family Planning
Vaginal Ring
Progesterone-only Pill
Combined Pill
Contraceptive Injection
Implant
Intrauterine System (IUS, Hormonal Coil)
Sterilisation
Morning After Pill
Abortion
Baby Moses Laws (US)
Adoption

 

Also, just as there are many different forms of female contraceptive (as shown in the table above), so too are there multiple forms of The Pill. For the reader’s leisure, and to really highlight the fact that women have a wide choice when it comes to The Pill, I have listed many of these contraceptives below (most were taken from Wikipedia, I have made some additions/amendments):

 

Combined Oral Contraceptive Pills (COCPs / COCs)

 

Monophasic (dosage stays the same throughout the course):

  • 15 µg ethinyl estradiol
    • 60 µg gestodene: 24 days + 4 days placebo (Spain: Melodene-15; Israel: Minesse)
  • 20 µg ethinyl estradiol
    • 1000 µg norethisterone acetate (UK: Loestrin 20, Galen; US: Loestrin 1/20, Duramed; Microgestin 1/20, Watson Pharmaceuticals; Junel 1/20, Barr)
    • 1000 µg norethisterone acetate: 24 days + 4 days ferrous fumarate only (US: Loestrin 24 Fe, Warner Chilcott)
    • 90 µg levonorgestrel: continuous: 365 days/year, no placebo (US: Lybrel, Wyeth)
    • 100 µg levonorgestrel (US: Alesse, Wyeth; Aviane, Barr; Lessina, Barr; Lutera, Watson; Sronyx, Watson)
    • 150 µg desogestrel (UK: Mercilon, Organon; RU: Novynette, Richter Gedeon)
    • 75 µg gestodene (UK: Femodette, Bayer; RU: Logest, Bayer; Brazil: Femiane, Bayer)
    • 3000 µg drospirenone: 24 days + 4 days placebo (US, EU, RU: Yaz; Bayer Schering Pharma AG. Cleonita); 21 days + 7 days placebo (US, EU: Yasminelle, Bayer); 24 days + 4 days placebo and levomefolate calcium (US: Beyaz; Bayer)
  • 30 µg ethinyl estradiol
    • 1500 µg norethisterone acetate (UK: Loestrin 30, Galen; US: Loestrin 1.5/30, Duramed; Microgestin 1.5/30, Watson; Junel 1.5/30, Barr)
    • 300 µg norgestrel (US: Lo/Ovral, Wyeth; Low-Ogestrel, Watson; Cryselle, Barr)
    • 150 µg levonorgestrel (UK: Ovranette, Wyeth; Microgynon 30, Microgynon 30 ED, Bayer; US: Nordette, Duramed, Levora, Watson, Portia, Barr)
    • 150 µg levonorgestrel: 21 day cycle + 7 days no pills (Canada: Min-Ovral 21; EU: Ovoplex 150/30; Sweden: Neovletta, Prionelle)
    • 150 µg levonorgestrel: 21 day cycle + 7 days placebo (Canada: Min-Ovral 28; Sweden: Prionelle 28; RU: Rigevidon 21+7, Richter Gedeon)
    • 150 µg levonorgestrel: extended cycle: 84 days + 7 days placebo (US: Seasonale, Duramed; Quasense, Watson; Jolessa, Barr, Introvale)
    • 150 µg levonorgestrel: extended cycle: 84 days + 7 days 10 µg ethinyl estradiol only (US: Seasonique, Duramed)
    • 75 µg gestodene (UK: Femodene, Femodene ED, Bayer; Minulet, Wyeth; RU: Femoden, Jenapharm)
    • 150 µg desogestrel (AU, EU, RU, UK: Marvelon, BR: Microdiol, US: Desogen, MSD; US: Ortho-Cept, Ortho-McNeil; RU: Regulon, Richter Gedeon)
    • 3000 µg drospirenone (AU, EU, US: Yasmin, FR: Jasmine, RU: Yarina, Bayer Schering Pharma AG); with levomefolate calcium (US: Safyral, Bayer Schering Pharma AG)
    • 2000 µg chlormadinone acetate (EU: Belara, Benelux: Bellina; Gedeon Richter)
    • 2000 µg dienogest (AU, EU: Valette, RU: Jeanine, Bayer Schering Pharma AG; RU: Siluet, Gedeon Richter)
  • 35 µg ethinyl estradiol
    • 400 µg norethisterone: chewable, spearmint flavor (US: Femcon Fe, Warner Chilcott)
    • 400 µg norethisterone (US: Ovcon 35, Warner Chilcott; Balziva, Barr)
    • 500 µg norethisterone (UK: Ovysmen, Janssen-Cilag; Brevinor, Pfizer; US: Modicon, Ortho-McNeil; Brevicon, Watson; Nortrel 0.5/35, Barr)
    • 1000 µg norethisterone (AU, CAN: Synphasic, Pfizer; UK: Norimin, Pfizer; US: Ortho-Novum 1/35, Ortho-McNeil; Norinyl 1/35, Watson; Necon, Watson; Nortrel 1/35, Barr)
    • 1000 µg etynodiol diacetate (US: Demulen 1/35, Pfizer; Zovia 1/35, Watson; Kelnor, Barr)
    • 250 µg norgestimate (UK: Cilest, Janssen-Cilag; US: Ortho Cyclen, Ortho-McNeil; MonoNessa, Watson; Sprintec, Barr)
    • 2000 µg cyproterone acetate: only approved for severe acne or severe hirsutism in the UK (AU, RU: Diane-35, UK: Dianette, Bayer)
    • 50 µg mestranol (equivalent to 35 µg ethinyl estradiol)
    • 1000 µg norethisterone (UK: Norinyl-1, Pfizer; US: Ortho-Novum 1/50; Ortho-McNeil; Norinyl 1/50, Watson; Necon 1/50, Watson)
  • 50 µg ethinyl estradiol
    • 1000 µg norethisterone (US: Ovcon 50, Warner Chilcott)
    • 1000 µg etynodiol diacetate (US: Demulen 1/50, Pfizer; Zovia 1/50, Watson)
    • 500 µg norgestrel (US: Ogestrel, Watson)
    • 250 µg levonorgestrel (US: Nordiol, Wyeth)
  • 5 mg estradiol (as hemihydrate)
    • 5 mg nomegestrol acetate: 24-day cycle + 4 placebo pills (AU, EU, RU: Zoely, MSD)

Multiphasic (dosage varies throughout course):

  • 25 µg ethinyl estradiol: triphasic
    • ethinyl estradiol/norgestimate combination with 7 tablets 25 µg/180 µg, 7 tablets 25 µg/215 µg, 7 tablets 25 µg/250 µg followed by 7 placebos (Ortho Tri-Cyclen Lo from Ortho-McNeil, Tri-Lo Sprintec back from Teva, Tri-Lo Marzia from Lupin, and norgestimate/ethinyl estradiol from Mylan)
    • ethinyl estradiol/desogestrel combination with 7 tablets 25 µg/100 µg, 7 tablets 25 µg/125 µg, 7 tablets 25 µg/150 µg, followed by 7 tablets of ferric oxide (US: Cyclessa, Organon; Velivet, Barr)
  • 20/30/35 µg ethinyl estradiol: estrophasic
    • ethinyl estradiol/norethisterone acetate combination with 5 tablets 20 µg/1000 µg, 7 tablets 30 µg/1000 µg, 9 tablets 35 µg/1000 µg, followed by 7 tablets of ferrous fumarate 75 mg (US: Estrostep Fe, Warner Chilcott)
  • 35/30/30 µg ethinyl estradiol: triphasic
    • ethinyl estradiol/desogestrel combination with 7 tablets 35 µg/50 µg, 7 tablets 30 µg/100 µg, 7 tablets 30 µg/150 µg (RU: Tri-Merci, Organon)
  • 30/40/30 µg ethinyl estradiol: triphasic
    • ethinyl estradiol/levonorgestrel combination with 6 tablets 30 µg/50 µg, 5 tablets 40 µg/75 µg, 10 tablets 30 µg/125 µg (UK: Trinordiol, Wyeth; Logynon, Logynon ED, Bayer; US: Triphasil, Wyeth; Trivora, Watson; Enpresse, Barr)
    • ethinyl estradiol/gestodene combination with 6 tablets 30 µg/50 µg, 5 tablets 40 µg/70 µg, 10 tablets 30 µg/100 µg (UK: Triadene, Bayer; Tri-Minulet, Wyeth)
  • 35 µg ethinyl estradiol: triphasic
    • ethinyl estradiol/norethisterone combination with 7 tablets 35 µg/500 µg, 9 tablets 35 µg/1000 µg, 5 tablets 35 µg/500 µg (UK: Synphase, Pfizer; US: Tri-Norinyl, Watson; Leena, Watson)
    • ethinyl estradiol/norethisterone combination with 7 tablets 35 µg/500 µg, 7 tablets 35 µg/750 µg, 7 tablets 35 µg/1000 µg (UK: TriNovum, Janssen-Cilag; US: Ortho-Novum 7/7/7, Ortho-McNeil; Necon 7/7/7, Watson; Nortrel 7/7/7, Barr)
    • ethinyl estradiol/norgestimate combination with 7 tablets 35 µg/180 µg, 7 tablets 35 µg/215 µg, 7 tablets 35 µg/250 µg followed by 7 placebos (Ortho Tri-Cyclen, Ortho-McNeil; TriNessa, Watson; Tri-Sprintec, Barr)
  • 35 µg ethinyl estradiol: biphasic
    • ethinyl estradiol/norethisterone combination with 10 tablets 35 µg/500 µg, 11 tablets 35 µg/1000 µg, followed by 7 placebos (US: Ortho-Novum 10/11, Ortho-McNeil; Necon 10/11, Watson)
    • ethinyl estradiol/norethisterone combination with 7 tablets 35 µg/500 µg, 14 tablets 35 µg/1000 µg (UK: BiNovum, Janssen-Cilag)
  • 3/2/1 mg estradiol valerate: estrophasic
    • estradiol valerate/dienogest combination with 2 tablets 3 mg/0 mg, followed by 5 tablets 2 mg/2 mg, 17 tablets 2 mg/3 mg, 2 tablets 1 mg/0 mg, and 2 placebos. (AU, EU, RU: Qlaira, US: Natazia, Bayer)

 

Progestogen-only Pills (POPs)

  • 350 µg norethisterone (norethindrone) (UK: Micronor, Janssen-Cilag; Noriday, Pfizer; US: Micronor, Ortho-McNeil; Nor-QD, Watson; Nora-BE, Watson; Jolivette, Watson; Camila, Barr; Errin, Barr; RU: Primolut-Nor, Bayer; Norkolut, Richter Gedeon)
  • 500 µg etynodiol diacetate (UK: Femulen, Pfizer)
  • 30 µg levonorgestrel (UK: Norgeston, Bayer; AUS, RU: Microlut, Bayer)
  • 75 µg desogestrel (UK: Cerazette, Loestrin; RU: Cerazette, Organon; Lactinette, Richter Gedeon; SE: Gestrina)
  • 500 µg lynestrenol (RU: Exluton, Organon)

 

Above are listed 51 different forms of ‘The Pill’ that women can take. I make specific effort to show these simply because I wish to show to the reader that a woman’s contraceptive options are not limited. If a woman is suffering adverse effects from The Pill, she can simply switch over to one that does not impede her or has a lesser effect on her. This option is not available for men. So thus, to compare the male contraceptive shot to The Pill and complain about an unfair double-standard against women is either dishonest, disingenuous or just plain stupid.

Ignoring all said stupidity on the internet, I wish to discuss the reasons behind why the MCS study shut down, the adverse effects the men suffered and why the adverse effects men suffered were worthy enough to shut down the study. I will also compare the male contraceptive to The Pill, however, due to the vast array of different forms of The Pill (as prior shown), I will have to limit my comparisons. I will be looking at ‘Levonorgestrel + ethinylestradiol’ and ‘norethisterone (norethindrone) + ethinyl estradiol’ as they are both on the World Health Organisation List of Essential Medicines (19th Edition, April 2015) and are both daily pills [I could wait an extra month for the 20th Edition but I’ve put off this article for long enough]. The other oral contraceptive on the list is an emergency morning after pill, so is thusly unsuitable for comparison.

The Pill Ladder.png

I stole the above image from here.

 

Male Contraceptive Shot

The study, linked here again, intended to test the possibility of a male contraceptive administered via an injection into the muscles (as per most jabs, but these were in the glutes). The injection contained 200-mg norethisterone enanthate, which is a steroidal progestin (acts similar to progesterone), and 1000-mg testosterone undecanoate, which is a long-acting synthetic form of testosterone. The testosterone inhibits fertility and the progestin limits the potential negative effects of what is essentially HRT.

It was administered every 8 weeks with the intention of reducing sperm count to 1 million per millilitre, the World Health Organisation recommended level of contraceptive protection. It is worth noting that some of the men had to rely on other forms of contraceptives for up to 26 weeks before they could rely purely on the shot (hardly fast acting stuff).

Of the 320 participants who received at least one injection, 274 suppressed to a sperm concentration less than or equal to 1million/mL by the end of 24 weeks (85.625% of participants), with a rate of 95.9 per 100 continuing users. The Pill has a contraceptive rate of 99%, the MCS is four times less effective. During the efficacy stage (MCS only, no other contraceptive methods used) there were 4 pregnancies, with a rate of 1.57 per 100 continuing users.

The design of the study went as follows:

The study protocol included a screening phase lasting up to 8 weeks, a suppression phase of up to 26 weeks (i.e., injections at 0, 8, 16, and 24 weeks), during which men received the intervention, an efficacy phase of up to 56 weeks with continued injections, during which eligible couples were exposed to the risk of pregnancy, and a recovery phase (beginning 8 weeks after the final injection) for up to 1 year.

study flow chart.jpg

Several men also underwent sperm rebound, that is to say that their sperm levels increased despite still receiving the shot. Six men exhibited sperm rebound during the 56 week efficacy phase – three of them had a sperm rebound with repeated sperm concentrations more than 1 million/mL at the first injection visit in efficacy phase (32 weeks since first injection), two men at the second injection visit in efficacy phase (40 weeks since first injection) and 1 man at the third injection visit in efficacy phase (48 weeks since first injection). Sperm concentrations at injection visits with sperm rebound ranged from 2.0 up to 16.6 million per millilitre (15 million per millilitre is the norm for ejaculate).

The cumulative rate of recovery for sperm count after 52 weeks was 94.8 per 100 continuing users, leaving men with a 5.2% of still being infertile a year after having used this contraceptive. After 52 weeks, eight men had not returned to fertile levels of sperm count. Five returned within 74 weeks, two dropped out and one did not return to normal fertility even after four years since his last injection.

The failure rate of the jab, if we include rebounds, pregnancies and non-suppression when the suppression phase had ended, was 7.5%.

 

Adverse Effects

 

The study was halted early due to adverse effects (AEs), most common of which were:

  • Acne
  • Injection site pain
  • Increased libido
  • Mood disorders

The study was shut down on the advice of an external safety review committee. To quote the study on why it was shut down:

The decision was based on RP2’s (The Research Project Review Panel) review of study AEs and conclusion that the risks to the study participants outweighed the potential benefits to the study participants and to the increased precision of the study outcome findings from having the full cohort contribute to the final analysis.

Neither the men in the study nor those conducting the study made the decision to halt it – it was decided independently.

I would like to point out that 80.1% of the men in the final visit reported being at least satisfied with the shot and 82.3% were willing to use it if it became available, so to argue that sissy men caused the study to be shut down because they couldn’t handle it would be hopelessly and hilariously false.

Participant Responses.png

S08: Suppression phase week 8. E00: Efficacy phase week 0. R00: Recovery phase week 0. FV: Final Visit.

The adverse effects suffered by the men ranged from changes in libido to gynaecomastia and severity ranged from mild to severe. These changes were judged to see if they were related to the shot.

Adverse Effects.png

Now, not that I’m one for conspiracy, but I suspect the motives of the independent panel can be questioned. Considering the vast majority of the AEs fell into the “Mild” column whereas 8.43% were considered “Moderate” and a mere 1.04% were classified as “Severe”, it seems questionable that the study would be suspended because the “risks to the study participants outweighed the potential benefits to the study participants”. The participants knew what they were getting into and what they were enduring, to quote the study again:

The AEs determined as “product-related” were not unexpected, had been previously reported after progestogen and/or testosterone administration, and were noted on the study consent form as possible side effects.

To argue that these risks were unexpected would be silly AND to argue that they posed a risk to the patients is ridiculous. They had provided consent and even at the end of the study, 80.1% of the men who were involved were “Satisfied/very satisfied”. I cannot see how “risks to the study participant” could be considered a valid reason for early termination of this study, from the evidence supplied.

The other reason they gave for ending the study prematurely was because said risks outweighed “the increased precision of the study outcome findings from having the full cohort contribute to the final analysis”. Essentially, the risks were causing too many people to drop out. 320 participants started the injections, 111 completed all the way to the recovery phase. That’s a drop-out rate of 65%. Sure, it’s not the greatest, but why did so many men drop out? Well, only 20 men dropped out because of product-related side-effects – that’s only 18.35% of all the drop-outs or 6.25% of the total men who started the injection! Is 6.25% that high a drop-out rate for people who have begun a medical trial, so high that it warrants the study to be shut down?

The study was shut down by the Research Project Review Panel (RP2), which was a department of the World Health Organisation’s Department of Reproductive Health and Research (WHO/RHR) – RHR has now become the Human Reproductive Programme (HRP). If you go to the WHO website, specifically Sexual and reproductive health, you’ll find this message about their vision:

Our vision is the attainment by all peoples of the highest possible level of sexual and reproductive health. It strives for a world where all women’s and men’s rights to enjoy sexual and reproductive health are promoted and protected, and all women and men, including adolescents and those who are underserved or marginalized, have access to sexual and reproductive health information and services. Our work is premised on the need to achieve access to and quality of sexual and reproductive health, in order to meet the needs of diverse populations, particularly the most vulnerable. [Emphasis mine]”

Yet, when I head to their “What’s new?” section (archive here as news updates), four out of the six news stories on the front page are female-orientated! That wouldn’t be so bad if the news topics affected only women yet, they are all universal problems (HIV, Genital Mutilation and State of Medical Facilities)! I smell Gynocentrism!

I would love to believe that the RP2 shut down the study with honest intentions but, considering the reasons that were provided and having given a cursory glance of the WHO website, I am somewhat sceptical. I also made an attempt at trying to find just exactly who sits on this panel yet, despite searching, I could not find such information! Perhaps, a more talented reader could find out for me.

Anyway, let’s step away from the land of tinfoil hats and back to the science.

 

Prevalence

 

Let’s compare the frequency of these adverse effects to the frequency of adverse effects in the two prior mentioned versions of The Pill. The two versions are Levonorgestrel + Ethinyl Estradiol (LEE) and Norethisterone (norethindrone) + Ethinyl Estradiol (NEE). I have created two tables, the first uses all prevalence columns and the second omits column titled “Yes Possible”. For the latter, my methodology is as follows (for each individual AE):

([Yes Probable + Yes Definite] / Total Number Reported AEs) * Number of Participants Reporting AE [% of 320 Participants]

E.g.

Acne:

([104 + 9] / 197) * 45.9

(113/197) * 45.9

0.57 * 45.9

26.3%

I discounted “Yes Possible” because a definition of “Possible” was not given in the study and I do not feel possible is a strong enough adjective to warrant the inclusion of the data. But, as I’m curious, I wanted to see its effects, hence the two tables. AEs that were deemed to not be related (38.8%) were removed by the study authors. Naturally, I cannot compare Injection Site Pain as The Pill is not an injection.

It is also worth noting that not all studies of The Pill that I cite below use the same dosage. So, a shaker of salt is served with each of the two tables below.

Prevalence of Adverse Effects - ALL.png

Prevalence of Adverse Effects - Probable & Definite.png

‘Factor’ denotes how much more a symptom is prevalent in MCS. Where ‘Factor’ is greater than one, AE is more prevalent in MCS. Where ‘Factor’ is lesser than one, AE is more prevalent in The Pill.

The studies used for the above tables are as

 

Levonorgestrel & Ethinyl Estradiol

 

Depression*

http://jamanetwork.com/journals/jamapsychiatry/article-abstract/2552796

 

All except Acne^, Depression, Musculoskeletal pain^ and Pregnancy – where AEs are classed as “≥ 1/100” I have used 1%, for others such as “≥ 1/1000, <1/100” I have used 0.002%

https://www.medicines.org.uk/emc/medicine/1827

 

Pregnancy – I used the effectiveness rate

https://onlinedoctor.lloydspharmacy.com/uk/combined-pill/microgynon-30-pill

 

Norethisterone (norethindrone) + ethinyl estradiol

 

All AEs

https://www.clinicaltrials.gov/ct2/show/results/NCT00477633?sect=X430156#othr

 

Depression. I found this review arguing that it is unlikely depression is a possible side-effect of Synphase.

http://factmed.com/report-SYNPHASE-causing-DEPRESSION.php

 

Emotional Disorder. The closest I could find were two studies consisting of three cases of panic disorder which correlated with the usage (and in turn, abstinence of) Synphase. These two studies were used as references on the “Ethinyl estradiol / norethindrone Side Effects” page on Drugs.com, so the studies should be taken with a pinch of salt.

 

*In this study, the percentage comes from the number of women who were using the pill and were prescribed anti-depressants. If feminists are willing to use this study as evidence of the pill causing depression (heralding it in the press) then, I can certainly use it here.

^Acne is not relevant as LEE seems to reverse acne in many women, thus seems improper to consider it an adverse effect if it is having the reverse effect on a negative symptom (this seems to be true for NEE also). As well as that, LEE seems to have no effect/does not cause any musculoskeletal pain.

+I found a second and a third study for effects of LEE on Libido. The second found no effect of Microgynon on libido but the third found for Microgynon 20 there was an increase in sexual desire but no effect with Microgynon 30.

~I could find no studies on the effects of NEE on Libido. I could, however, find plenty of blog posts of women who have been on NEE complaining that their sex drive is either flat-lining or sky-rocketing, as well as blog posts of women wondering what in heck all the other women are talking about.

 

I did, however, find this study on COCs and libido. A meta-analysis of 35 studies spanning 1978 – 2011, it reviewed data on 8,422 women who were COC users. 63.6% reported no change in libido, 21.7% reported an increase and 14.7% reported a decrease. Increase in libido is 1.76x as prevalent in the Male Contraceptive Shot but decrease in libido is 3.56x as prevalent in COC usage. This, however is broad brush, containing a variety of COCs, so difficult to define which pill is causing this. I will also note that the study did not review any COCs which contained noresthisterone/norethindrone. Ergo, it would be improper to use this study to compare MCS with brands such as Synphase or Loestrin. The study did review COCs with Levonorgestrel, so Microgynon can be considered. One could argue, considering the table above, that Levonorgestrel decreases the female sex drive. [One study found that of women who use a Levonorgestrel Intrauterine System, 33% reported a sexual dysfunction. Of those, 20% reported an increased sexual desire, 25% a decreased sexual desire, 5% arousal problems, and 8% orgasm problems.]

Where I could not find data or where it was not relevant I have filled the fields with “n/a”

If we limit our scope to the AEs mentioned in the Fusion video (for those with short memories, they are: Depression, Mood Swings, Low Libido, Weight Gain and Muscle Pain, as she calls it) and those studied in the second table, we see that these AEs were considerably more prevalent in the MCS than in The Pill (except for Depression & Headache with LEE and Weight Gain with NEE, where the differences are small). The arrogant flippancy of the presenter in the Fusion video implies she is oblivious to this fact. She complains of a double standard but, really, she’s just stupid.

 

Severity

 

Earlier, I commented on how the vast majority of the AEs fell into the “Mild” column, a whopping 90.53%, whereas 8.43% were considered “Moderate” and a mere 1.04% were classified as “Severe”, proving that the AEs weren’t too inhibiting (according to the participants). Tabled below are the same AEs as before, this time considering severity (ignoring Mild AEs).

Severity of Adverse Effects of the Male Contraceptive Shot.png

When we consider the data as presented above, we see that 0.9% of men suffered a severe increase in libido (is suffered really the correct word?) and 3.7% suffered a moderate increase in libido. However, this does not take into account whether they are Possibly related to the study, Probably related or Definitely related. As I seem to be a glutton for punishment, I have created such a table for the reader’s pleasure.

Prevalence of Severity of AEs of the Male Contraceptive Shot (%).png

The worst offenders are Acne and Increased Libido. 2.2% of MCS users suffered Moderate Acne that was of Probable relation to the MCS and 1.9% of MCS users suffered Moderate Libido Increase that was of Definite relation to the MCS (0.5% suffered Severe).

Look how empty the Severe section is, a sea of zeroes. Even the Moderate section is incredibly lacklustre. Yet, the study was still shut down. I agree with the sentiment the idiot woman in the Fusion video is trying to convey, the Adverse Effects suffered, the prevalence and severity of them, did not warrant the closing of the study. But, what do I know? Evidently, I am missing something that the review board did not.

Most studies that I looked at for severity of adverse effects when using The Pill seemed to focus purely on dysmenorrhea, amenorrhea, spotting and breakthrough bleeds. Some did assess additional AEs, such as this and this but, I could not find a satisfactory study that fully assessed the severity of AEs. A clinical trials study would have been nice unfortunately, I could not find one (if a reader finds one that can be used, please be ever so kind as to comment it below). I can therefore, make no comparisons.

I will comment that I found a plethora of blog posts by women anecdotally and subjectively arguing the severity of AEs suffered because of The Pill. However, as many of these posts did not cite which specific pill they were on I could not include them in my analysis. Shame.

 

Conclusion

 

It would appear that Adverse Effects are more prevalent in the MCS than they are in The Pill, depending on whether we are assessing how likely they are and which pill we are comparing with. The severity of the AEs seem not to be that great, the vast majority were mild and the majority of the male participants were satisfied with the shot. The only three snags, in my opinion, are that the contraceptive is a shot (I hate needles, which is ironic considering I am tattooed and have several facial piercings), the prolonged period of time before efficacy and that one guy who was rendered permanently infertile because of the shot. Sort those three out and I’ll be happy to take this new form of contraceptive.

I would like to add, and this is a point I really want to stress, despite all the doom and gloom in this article, we are not to give up on the male contraceptive. Be it a shot or a pill, there is a lot of potential for male contraceptives and, like many previous medicines, this one has hit a few snags.

2 comments

  1. I wouldn’t let that damned know-all William Collins put you off posting. Rumour has it he’s just pissed off you got to squeeze Cassie Jaye and he didn’t. In any case, we need more posts on male contraception and this one is far more detailed than his puny effort.

    I’m inclined to think that hormonal methods are not the best strategy for men. In the case of women, hormonal methods are essentially just a tweak to their natural monthly cycle. Women do not drop eggs most of the time. The Pill just extends this to never. But men do produce sperm all the time. So stopping sperm production is more unnatural. So it is not surprising that hormonal methods have greater side effects in men.

    On the other hand, non-hormonal drugs and medical ‘devices’ are more promising for men. In fact men have a great advantage over women in respect of ‘devices’, seeing as how their bits are so easily get-at-able. (Stop me if this is getting too technical). There is no good technical reason for the absence of a male contraceptive already, in my unhumble opinion.

    I did find the story behind stopping the trials a little suspect – mostly because the internal Safety Panel gave it the go-ahead, and it was only stopped by the WHO’s external generic research monitoring body. As you suggest, there is probably not enough here to justify donning the tinfoil hat, but nevertheless a slight whiff of fish. Also, why did this story hit the media as ‘stop press’ when the trials had actually been stopped nearly 5 years earlier?

    Having said that, personally I think I’d have stopped the trials, too. Did you mention suicide? The one suicide that occurred was not attributed to the trials. But there was also an attempted suicide. Two out of 320 is way above expectation. Another issue which is not brought out emphatically in the research report is the weak recovery in sperm production. Taking a year to achieve 95% of men to recover a nominally ‘fertile’ sperm count is bad enough – but worse, in my view, is that the nominal ‘fertile’ level adopted was way lower than the men’s starting sperm count. In fact it was less than half of the lowest of the men’s sperm counts prior to the trial. There has to be questions about the degree of reversibility.

    However…all this is detail. My main point is this: it’s just fine and dandy by me if the wimmins get all sarcastic about the baby menz, etc., as per Fusion and others. It’s absolutely great if the wimmins start promoting male contraception. I don’t care if they see it as ‘sharing the burden / responsibility’. It’s a jolly good thing that their understanding of current gender issues is so poor that they fail to understand what a game-changer an effective male contraceptive would be. It is the only reasonably likely development which could redress the current power imbalance. Long may their limited grasp of reality continue.

    Unfortunately their bigger sisters are unlikely to be so naive. And male contraceptive initiatives may continue to flounder on underfunding for clinic trials, or spurious ‘ethical’ blockers.

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