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ISRCTN
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ISRCTN56557137
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ClinicalTrials.gov identifier
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Public title
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New formulation of testosterone undecanoate in hypogonadal men: a pharmacokinetic and pharmacodynamic study of a novel formulation of testosterone undecanoate in hypogonadal Asian men
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Scientific title
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Acronym
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N/A
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Serial number at source
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WHO/HRP ID A25166
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Study hypothesis
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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Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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China, Indonesia, possibly India
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Disease/condition/study domain
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Male contraception
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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No exclusion criteria
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Anticipated start date
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01/01/1997
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Anticipated end date
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01/01/1999
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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72
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Interventions
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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.
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Primary outcome measure(s)
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1. Circulating concentrations of testosterone at 12 weeks
2. Profile of testosterone concentrations over time at 12 weeks
3. Gonadotropin concentrations at 12 weeks
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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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).
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Trial website
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Publications
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Contact name
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Dr
Kirsten
Vogelsong
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Address
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World Health Organization
20 Avenue Appia
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City/town
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Geneva
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Email
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vogelsongk@who.int
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Sponsor
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UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
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Address
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World Health Organization
20 Avenue Appia
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City/town
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Geneva
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Zip/Postcode
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CH-1211
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Country
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Switzerland
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Sponsor website:
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http://www.who.int/reproductive-health/hrp/
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Date applied
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23/03/2004
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Last edited
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10/09/2007
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Date ISRCTN assigned
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01/04/2004
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