Table 2.
Adverse events reported in larger scale male contraceptive clinical trials (over 50 men per group)
| Clinical trial | Adverse events (% of enrolled subjects) | |||||||
|---|---|---|---|---|---|---|---|---|
| N | Pain/problems with injection/implant | Acne | Weight gain | Mood changesg | Libido changesh | Behavior changei | Fatigue | |
| Testosterone only | ||||||||
| TE [13] | 271 | 7.5 | 29.5 | 4.4 | 1.5 | 4.4 | 2.6 | 8.1 |
| TE [14]a | 399 | 5.3 | 2.0 | 0.5 | 1.0 | 0.8 | 0.8 | 0 |
| TU 2003 [27] | 308 | + | 6.8 | + | 0 | + | 0 | 0 |
| TU 2009 [28••]b | 1045 | 3.9 | 7.4 | + | 0.8 | + | ? | 0 |
| Testosterone + Progestin | ||||||||
| T implants DMPA [19]a,c | 55 | 10.9 | ? | + | 1.2 | + d | ? | + d |
| TU+ Etonogestrel implants [42•]e | Active 297 | 0.6 | 26 | 24 | 19 | 13 | ? | + |
| Placebo 52 | 2 | 10 | 10 | 10 | 0 | ? | ? | |
| TU + NET-EN [29•]f | 320 | 23.1 | 45.9 | 3.8 | 24.4 | 42.2 | 5.7 | 1.6 |
TE testosterone enanthate, TU testosterone undecanoate, DMPA depot medroxyprogesterone acetate, NET-EN norethisterone enanthate
aOnly adverse events leading to discontinuations reported (italics)
bCough after injections in 2.1 %; facial swelling/rash 0.8 %
cTwo serious adverse events: myotonic dystrophy during recovery phase and multiple congenital malformations (Vater Anomalad) in one twin conceived during recovery phase. Both considered not related
dSymptoms of hypogonadism (lethargy and sexual dysfunction) occurred in men during month 5 or 6 after T implants because of inadequate testosterone release from the pellets after 4 months. This necessitated a protocol amendment
eNight sweating was reported in 27 % of men in the active group versus 8 % in the placebo group
fMost of the adverse events are mild or moderate, and many occurred in one center: acne (90 % mild), mood changes (includes 16.9 % emotional changes, 97 % mild; 4.7 % mood swings; 84 % mild; and 2.8 % depression, five subjects had moderate and two subjects had severe depressive mood/depression), injection site pain (93 % mild), libido changes (mainly increase; 88 % mild), and behavior changes (83 % mild)
gMood changes include emotional disorder, mood swings, altered mood, and depression
hLibido changes include increase or decrease libido
iBehavior changes include aggression or hostility