Testosterone undecanoate combined with depomedroxyprogesterone acetate in two month intervals in Asian men
| ISRCTN | ISRCTN31330564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31330564 |
| Protocol serial number | WHO/HRP ID A15242 |
| Sponsor | UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction |
| Funder | United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP) |
- Submission date
- 22/03/2004
- Registration date
- 01/04/2004
- Last edited
- 20/08/2008
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kirsten Vogelsong
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland
| vogelsongk@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess the efficacy of 500 mg Testosterone Undecanoate (TU) in combination with either 150 or 250 mg Depomedroxyprogesterone Acetate (DMPA) in suppression of sperm production, while maintaining adequate testosterone levels in fertile Asian men. Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Male contraception |
| Intervention | 1. 500 mg TU and 150 mg DMPA injected at eight week intervals (n = up to 32) 2. 500 mg TU and 250 mg DMPA injected at eight week intervals (n = up to 32) |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Testosterone undecanoate (TU), depomedroxyprogesterone acetate (DMPA) |
| Primary outcome measure(s) |
1. Changes in sperm concentrations to azoospermia or severe oligozoospermia at 24 weeks |
| Key secondary outcome measure(s) |
Suppression of gonadotropins and maintenance of normal blood testosterone levels at 24 weeks. |
| Completion date | 01/06/2004 |
| Reason abandoned (if study stopped) | Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 64 |
| Key inclusion criteria | 1. Men in good health, aged 20 to 45 2. No desire for children for next 15 months 3. Normal reproductive state: a. sperm concentrations greater than or equal to 20 million/ml b. sperm motility greater than 50% (rapid and slow progressive) or grade a greater than 15% c. morphology greater than 15% normal forms using the World Health Organisation (WHO) strict criteria, or d. within the normal range for the centre 4. Body mass index between 20 and 29 kg/m^2 |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- China
- India
- Indonesia
- Switzerland
Study participating centre
World Health Organization
Geneva
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
