Testosterone undecanoate combined with depomedroxyprogesterone acetate in two month intervals in Asian men

ISRCTN ISRCTN31330564
DOI https://doi.org/10.1186/ISRCTN31330564
Secondary identifying numbers WHO/HRP ID A15242
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

World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland

vogelsongk@who.int

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory.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) studiedMale contraception
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Testosterone undecanoate (TU), depomedroxyprogesterone acetate (DMPA)
Primary outcome measure1. Changes in sperm concentrations to azoospermia or severe oligozoospermia at 24 weeks
2. Time to suppress spermatogenesis at 24 weeks
Secondary outcome measuresSuppression of gonadotropins and maintenance of normal blood testosterone levels at 24 weeks.
Overall study start date01/06/2003
Completion date01/06/2004
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stopped)Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory.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 groupAdult
SexMale
Target number of participants64
Key inclusion criteria1. 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 criteriaNo exclusion criteria
Date of first enrolment01/06/2003
Date of final enrolment01/06/2004

Locations

Countries of recruitment

  • China
  • India
  • Indonesia
  • Switzerland

Study participating centre

World Health Organization
Geneva
CH-1211
Switzerland

Sponsor information

Funders

Funder type

Research organisation

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
BMC - Part of Springer Nature Springer Nature