Table 2.
Contraceptive efficacy of MHC regimens
| Regimen | N Enrolled | Sperm Conc^ (M/mL) | N (%)Failed to suppress^^ | Median time to enter efficacy (months) | N Entered Efficacy | Maximum Treatment Duration (months) | Pregnancies During Efficacy n (%) | Exposure person year | Failure rate/100 couple yr |
|---|---|---|---|---|---|---|---|---|---|
| a TE 32 | 271 | 0 | 68 (25) | < 6 | 157 | 18 | 1 (0.6) | 123.8 | 0.8 (0.02 – 4.5) |
| b TU 12 | 1045 | 1 | 43 (5) | 3.6 | 855 | 30 | 9 (1.1) | 1554.1 | 1.1 (0.4 – 1.8) |
| c T implant 34 | 55 | 1 | 2 (4) | 1.8 | 51 | 18 | 0 (0.0) | 35.5 | 0 (0.0 – 8.0) |
| a TE 25 | 399 | 3* | Not reported* | 2.2 | 349 | 18 | 11 (3.1) | 279.9 | 1.4 (0.4 – 3.7) |
| b TU 33 | 308 | 3 | 9 (3) | 2–3 | 296 | 12 | 1 (0.3) | 143 | 2.3 (0.5 – 4.2) |
| Total (0, 1, 3) | 2078 | 0, 1, 3 | 122 (7) | 1708 | 12–30 | 22 (1.3) | 2136.3 | 1.0 (0.7 – 1.6) ¶ | |
| Total (0, 1) | 1371 | 0, 1 | 113 (8) | 1063 | 18–30 | 10 (0.9) | 1713.4 | 0.6 (0.3 – 1.1) ¶ | |
| Total (1) | 1100 | 1 | 45 (4) | 906 | 18–30 | 9 (1.0) | 1589.6 | 0.6 (0.3 – 1.1) ¶ |
^
Sperm concentration required to enter efficacy;
^^
Failed to suppress to sperm concentration required to enter efficacy by 6 months
a
testosterone enanthate 200 mg/week;
b
testosterone undecanoate 500 mg/month (with 1000 mg loading dose);
c
testosterone implant 800 mg every 4 months with DMAP 300 mg every 3 months
*
Original threshold was 5 M/mL, but data shown here is for those who suppressed to no more than 3 M/mL
¶
Studies pooled and 95% Poisson confidence limits calculated using SAS 9.3 (Cary, NC).