Assessing acceptability and sexual behaviour during male contraception: mood, behavior and user's perspectives related to sperm suppression with norethisterone enanthate (NET-EN) plus testosterone undecanoate (TU) in normal men

INTERVENTION: Pre‐treatment control period for 4‐6 weeks; then treatment for 48 weeks; and a post‐treatment recovery period of at least 18 weeks. Treatment groups are: Group 1: Net‐En 200 mg/six weeks plus TU 1000 mg/six weeks for 12 weeks followed by Net‐En 200 mg/12 weeks plus TU 1000 mg/12 weeks for 36 weeks (n = 10) Group 2: Net‐En 200 mg/six weeks plus TU 1000 mg/six weeks for 12 weeks followed by placebo/12 weeks + TU 1000 mg/12 weeks for 36 weeks (n = 10) Group 3: Net‐En 200 mg/eight weeks plus TU 1000 mg/eight weeks for 48 weeks (n = 10) Group 4: Net‐En 200 mg/12 weeks plus TU 1000 mg/12 weeks for 48 weeks (n = 10) Group 5: Placebo/six weeks for 12 weeks followed by placebo/12 weeks for 36 weeks (n = 10) Group 6: Untreated controls (n = 40) CONDITION: Male contraception ; Not Applicable ; Contraception PRIMARY OUTCOME: Current primary outcome measures as of 10/09/2007:; 1. Attitudes towards contraception; 2. Motivation to participate in the clinical trial; 3. Reactions to the various treatment regimens; 4. Overall assessment of the method; 5. Reports of physical status, mood, sexual function and behaviour; ; Previous primary outcome measures:; 1. Socio‐demographic and economic profile of study participants; 2. Motivating factors for participation in the trial; 3. Contraceptive history of participant and partner; 4. Side effects experienced during the study; 5. Measurements of sexual function; 6. Measurements of aggression, irritability, and other mood states; 7. Measurement of user's perspectives and acceptability; ; Follow‐up duration for primary endpoints: 72 ‐ 74 weeks, including control (baseline) period. SECONDARY OUTCOME: 1. Background characteristics of participants; 2. Contraceptive history; 3. Reports of partners' reactions INCLUSION CRITERIA: Current inclusion criteria as of 10/09/2007: Male participants were recruited according the the recruitment strategy, inclusion criteria and exclusion criteria outlined on page 13 of clinical protocol number 303923 "NET‐EN plus TU for male contraception" The World Health Organization did not support the clinical trial, but sponsored this acceptability component. Previous INCLUSION CRITERIA: Same as those for the protocol for the clinical evaluation of the safety and efficacy of the hormonal regimens. The clinical component is supported by the private sector and supported by the World Health Organization (WHO) Department of Reproductive Health and Research; therefore, we do not have access to the protocol.