New formulation of testosterone undecanoate in hypogonadal men: a pharmacokinetic and pharmacodynamic study of a novel formulation of testosterone undecanoate in hypogonadal Asian men
| ISRCTN | ISRCTN56557137 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56557137 |
| Protocol serial number | WHO/HRP ID A25166 |
| Sponsor | UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP) |
| Funders | 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), Test compounds donated by manufacturer (Xianju Pharmaceutical Corporation, Zhejiang, People's Republic of China). |
- Submission date
- 23/03/2004
- Registration date
- 01/04/2004
- Last edited
- 10/10/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
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 | 1. Describe the Pharmacokinetic (PK) profile of a new formulation of Testosterone Undecanoate (TU) (250 mg/ml in soy bean oil); and 2. Compare two doses of this formulation of TU with a single dose of formulations that are currently being evaluated in clinical trials Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory.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 | Hypogonadism |
| Intervention | Study participants will be randomised to receive a single administration (injection) of one of the following: 1. 500 mg of the novel TU formulation 2. 1000 mg of the novel TU formulation 3. 1000 mg of 125 mg/ml TU in tea seed oil 4. 1000 mg of 250 mg/ml TU in caster oil. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Testosterone undecanoate |
| Primary outcome measure(s) |
1. Circulating concentrations of testosterone at 12 weeks |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/01/1999 |
| 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 directory. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 72 |
| Key inclusion criteria | 1. Male participants age 18 to 50 years 2. Diagnosed with hypogonadism (androgen values below the normal range for the centre) 3. Not concurrently undergoing other androgen therapy |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 01/01/1999 |
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 |
