Table 1.
Contraceptive efficacy in hormonal male contraception clinical trials
Study reference | Sperm concentration threshold million/ml | Drugs | Number enrolled | Number completing suppression phase (6 m) | Number reaching threshold | Number entering efficacy | Number completing efficacy | Number with sperm rebound | Years of exposure to risk of pregnancy | Pregnancies/failure ratea |
---|---|---|---|---|---|---|---|---|---|---|
WHO 1990 [13] | Azoospermia | TE 200 mg/week | 271 | 225 (83 %) | 157 (70 %) | 157 | 119 | 21 (1.4 %) | 123.8 | 1 |
0.8 (0.0–45.)a | ||||||||||
WHO 1996 [14] | <3 (reduced form <5) | TE 200 mg/week | 399 | 357 (89 %) | 349 (97.8 %) | 268 | 209 | 4 (0.2 %) | 279.9 (230.4 azoospermia) | 4 |
1.4 (0.4–3.7)a | ||||||||||
McLachlan et al 2000 [15] | <1 | T implants 800 or 1200 mg/4 months | 36 | 29 | 21 (72 %) | 16 | 17 | 4 | 17.8 | 0 |
Turner et al 2003 [19] | <1 | T implants 800 mg/4–6 months DMPA 300 mg/3 months | 55 | 55 | 53 (94 %) | 51 | 30 | 0 with T implants/4 months | 35.5 | 0 (0–8)a |
Gu et al 2003 [27] | <3 | TU 1000 mg loading 500 mg/month | 308 | 308 | 299 (97.1 %) | 296 | 280 | 6 (2.3 %) | 143 | 0 |
1 in sperm rebound 2.3 (0.5–4.2)a | ||||||||||
Gu et al 2009 [28••] | <1 | TU 1000 mg loading 500 mg/month | 1045 | 898 | 855 (95.2 %) | 855 | 733 | 10 (1.3 %) | 1554.1 | 9 |
1.1 (0.4–1.8)a | ||||||||||
WHO/CONRAD 2015 [29•] | <1 | TU 1000 mg and Net–EN 200 mg/8 weeks | 320 | 283 | 274 (95.9 %) | 266 | 111b | 6 | ? | 4 |
1.57 (0.59–4.14) | ||||||||||
2.18 (0.82–5.80)a |
T testosterone, TE testosterone enanthate, TU testosterone undecanoate, DMPA depo-medroxyprogesterone acetate, NET-EN norethisterone enanthate
aPearl rate (95 % confidence interval) per 100 couple-year
bTrial terminated before planned end of study