TABLE 1.
Study (Ref.) | n | Study centers | Androgen | Progestin | No. of groups | Random allocation | Treatment duration (wk) | Age (yr) | Semen sampling interval (wk) |
---|---|---|---|---|---|---|---|---|---|
WHO (2 ) | 399 | 15 | TE 200 mg/wk | None | 1 | N/A | 52–781,b | 21–45 | 4 |
Gu et al. (3 ) | 308 | 6 | TU 500 mg per 4 wk (1000 mg loading dose) | None | 1 | N/A | 26–521,d | 20–45 | 4 |
WHO (1 ) | 271 | 10 | TE 200 mg/wk | None | 1 | N/A | 52–781,d | 21–45 | 4 |
Hay et al. (29 ) | 112 | 6 | TD 400 mg per 4–6 wk | Oral ENG 300 μg/d | 2 | Yes | 48 | 18–45 | 4 |
Wang et al. (30 ) | 80 | 2 | T pellet 800 mg per 15–18 wk | LNG 0–4 rods2 | 2 | Yes | 30–36 | 24–50 | 3 |
Wang et al. (31 ) | 72 | 3 | MENT 2–3 rods3 | LNG 0–4 rods2 | 4 | Yes | 52 | 20–45 | 4 |
Gonzalo et al. (32 ) | 68 | 1 | T patch (10 mg/d) or TE4 | LNG 4 rods or oral LNG 0–125 μg/d2 | 4 | Yes | 24 | 18–50 | 3 |
Kinniburgh et al. (33 ) | 66 | 2 | T pellet5 | DSG6 | 2 | Yes | 24 | 22–41 | 4 |
Turner et al. (4 ) | 55 | 2 | T pellet 800 mg per 16–24 wk | DMPA 300 mg/12 wk | 2 | No | 52–781,c | 18–50 | 4 |
Amory et al. (34 ) | 51 | 1 | TE 25–300 mg/wk | None | 5 | Yes | 24 | 18–50 | 2 |
Meriggiola et al. (35 ) | 50 | 1 | TU 1000 mg per 6–12 wk | NET 0–200 mg/6–12 wk | 5 | Yes | 48 | 18–50 | 2 |
Kamischke et al. (36 ) | 42 | 1 | TU 1000 mg per 6 wk | NET 200–400 mg/6 wk or oral NET 10 mg/d | 3 | Yes | 24 | 18–45 | 4 |
Anawalt et al. (37 ) | 41 | 1 | TE4 | Oral LNG 31.25–62.5 μg/d | 2 | Yes | 24 | 18–51 | 2 |
Qoubaitary et al. (38 ) | 40 | 2 | TU 750-1000 mg per 8 wk | NET 0–200 mg/8 wk | 4 | Yes | 24 | 18–50 | 4 |
Bebb et al. (39 ) | 36 | 1 | TE4 | Oral LNG 0–500 μg/d | 2 | Yes | 24 | 20–42 | 2 |
Anawalt et al. (40 ) | 36 | 1 | TE4 | Oral LNG 125–250 μg/d | 2 | Yes | 24 | 20–46 | 2 |
Von Eckardstein et al. (41 ) | 35 | 3 | MENT 1–4 rods7 | None | 3 | Yes | 26–52 | 20–45 | 4 |
Gu et al. (42 ) | 30 | 1 | TU 1000 mg per 8 wk | DMPA 0–300 mg/ 8 wk | 3 | Yes | 24 | 20–45 | 4 |
Kamischke et al. (43 ) | 28 | 1 | TU 1000 mg per 6 wk | Oral LNG 0–250 μg/d | 2 | Yes | 24 | 18–45 | 4 |
Anderson et al. (44 ) | 28 | 1 | T pellet5 | ENG 1–2 rods8 | 2 | Yes | 24 | 21–39 | 4 |
Wu et al. (45 ) | 24 | 1 | TE 50–100 mg/wk | DSG6 | 3 | Yes | 24 | 18–50 | 4 |
Meriggiola et al. (46 ) | 24 | 1 | TU 1000 mg per 6–8 wk | Oral CPA 0–20 mg/d | 3 | Yes | 44 | 18–45 | 4 |
Anawalt et al. (47 ) | 24 | 1 | TE 50–100 mg/wk | DSG6 | 3 | Yes | 24 | 20–49 | 2 |
Hair et al. (48 ) | 23 | 1 | T patch 5 mg/d | DSG 75–300 μg/d | 3 | Yes | 24 | 20–43 | 4 |
Meriggiola et al. (23 ) | 18 | 1 | TE 100–200 mg/wk | Oral CPA 5 mg/d | 2 | Yes | 16 | 21–45 | 2 |
Brady et al. (49 ) | 15 | 1 | T pellet5 | ENG 3 rods8 | 1 | N/A | 24–48 | 18–37 | 4 |
Meriggiola et al. (50 ) | 15 | 1 | TE4 | Oral CPA 0–100 mg/d | 3 | Yes | 16 | 22–44 | 2 |
Kamischke et al. (51 ) | 14 | 1 | TU 1000 mg per 6 wk | NET 200 mg/6 wk | 1 | N/A | 24 | 18–45 | 4 |
Meriggiola et al. (52 ) | 10 | 1 | TE4 | Oral CPA 12.5–25 mg/d | 2 | Yes | 16 | 19–42 | 2 |
Meriggiola et al. (53 ) | 8 | 1 | T capsule 160 mg/d | Oral CPA 25 mg/d | 1 | N/A | 16 | 25–42 | 2 |
Efficacy studies (end point being contraceptive failures) or suppression studies (end point being suppression of spermatogenesis). For these efficacya studies, treatment was ceased after 6 months if sufficient suppression of sperm concentration to azoospermia,b less than 1 million/mlc or less than 3 million/ml,d had not occurred. For all studies, volunteers (n = 2023) were enrolled only after a normal physical examination, normal blood electrolytes, hematology and hormones, and normal semen analysis (i.e. sperm concentration > 20 million/ml). N/A, Not applicable.
Each LNG rod contains 75 mg and releases 36–49 μg/d.
Each MENT rod releases 500 μg/d.
TE 100 mg/wk.
T pellet 400 mg per12 wk.
Oral DSG 150–300 μg/d.
Each MENT rod releases 400 μg/d.
Each ENG rod contains 68 mg and releases about 50 μg/d.