Male contraception Pregnancy and Childbirth Contraception
Conditions
Interventions
1. 500 mg TU injections at six week intervals (n = 20)
2. 500 mg TU injections at six week intervals and 300 mg DMPA injections at 12 week intervals (n = 20)
Injections administered for up to 48 wee
participants followed for recovery in semen parameters for an additional 48 weeks.
Sponsors
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 24/09/2007: Male participants: 1. Age 21 to 45 years 2. Good general health 3. Blood parameters (peptide hormones, clinical chemistry, haematology, Prostate Specific Antigen [PSA]) in normal range 4. Semen parameters in normal range: 4.1. Sperm concentration 20 million/mL 4.2. Sperm morphology greater than 30% normal 4.3. Sperm 50% forwardly motile 5. Couples must be in a stable relationship, dissatisfied with their current method of contraception and have no history of infertility Female partners: 1. Age of consent to 35 years 2. Regular menstrual cycles 3. No history of Pelvic Inflammatory Disease (PID) in last 12 months 4. Not pregnant 5. Willing to have physical exam and to participate in trial Previous inclusion criteria: Male participants: 1. Age 21 to 45 years 2. Good general health 3. Blood parameters (peptide hormones, clinical chemistry, haematology) in normal range 4. Semen parameters in normal range: a. sperm concentration 20 million/mL b. sperm morphology greater than 30% normal c. sperm 50% forwardly motile Female partners: 1. Age of consent to 35 2. Regularly cycling 3. No history of Pelvic Inflammatory Disease (PID) in last 12 months 4. Not pregnant 5. Willing to have physical exam and to participate in trial
Exclusion criteria
Exclusion criteria: Added 24/09/07: 1. History of active or chronic cardiac, renal, hepatic or prostatic disease or other serious diseases such as diabetes mellitus, hyperlipoproteinemia, etc. 2. Men with active or persistent genitourinary infection 3. Use of medication such as sex steroids or barbiturate 4. Couples in which the wife is breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Azoospermia (no sperm present in ejaculate) or severe oligozoospermia (less than 1 million sperm/mL) 2. Pregnancy 3. Time to suppress spermatogenesis Follow-up duration for primary endpoints: up to 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 24/09/2007: 1. Safety 2. Side effects | — |
Countries
Indonesia
Outcome results
None listed