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ISRCTN
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ISRCTN31330564
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ClinicalTrials.gov identifier
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Public title
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Testosterone undecanoate combined with depomedroxyprogesterone acetate in two month intervals in 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 A15242
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Study hypothesis
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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Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory.
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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, India, Indonesia
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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. 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
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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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01/06/2003
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Anticipated end date
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01/06/2004
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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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64
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Interventions
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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)
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Primary outcome measure(s)
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1. Changes in sperm concentrations to azoospermia or severe oligozoospermia at 24 weeks
2. Time to suppress spermatogenesis at 24 weeks
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Secondary outcome measure(s)
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Suppression of gonadotropins and maintenance of normal blood testosterone levels at 24 weeks.
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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)
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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
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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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22/03/2004
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Last edited
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20/08/2008
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Date ISRCTN assigned
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01/04/2004
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