Contact information
Type
Scientific
Primary contact
Dr Kirsten Vogelsong
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
vogelsongk@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WHO/HRP ID A05082
Study information
Scientific title
Acronym
Study hypothesis
To assess the efficacy of 500 mg of Testosterone Undecanoate (TU) alone or combined with Depot Medroxyprogesterone Acetate (DMPA) to suppress sperm production in fertile Indonesian men.
Please note that as of 24/09/07 this trial record was updated significantly by the World Health Organization (WHO) Technical Officer. The title was amended from 'Effect of Testosterone Undecanoate (TU) combined with Depomedroxyprogesterone Acetate (DMPA) on sperm production' to the above title, and any other changes to this record will be mentioned under the date 24/09/2007.
Ethics approval
As of 24/09/2007 ethics approval received from:
1. National Family Planning Coordinating Board, Indonesia: approval granted 26 November 1997
2. Sriwijaya University, Palembang, Indonesia approval granted 11 June 1998
3. University of Indonesia approval granted 31 August 1998
4. WHO/HRP Scientific and Ethical Review Group approval granted 30 October 1998
5. WHO Secretariat committee for research involving human subjects approval granted 3 November 1999
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Male contraception
Intervention
1. 500 mg TU injections at six week intervals (n = 20)
2. 500 mg TU injections at six week intervals and 300 mg DMPA injections at 12 week intervals (n = 20)
Injections administered for up to 48 weeks; participants followed for recovery in semen parameters for an additional 48 weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
Testosterone Undecanoate (TU), Depot Medroxyprogesterone Acetate (DMPA)
Primary outcome measures
1. Azoospermia (no sperm present in ejaculate) or severe oligozoospermia (less than 1 million sperm/mL)
2. Pregnancy
3. Time to suppress spermatogenesis
Follow-up duration for primary endpoints: up to 48 weeks
Secondary outcome measures
Added as of 24/09/2007:
1. Safety
2. Side effects
Overall trial start date
01/07/2000
Overall trial end date
01/07/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 24/09/2007:
Male participants:
1. Age 21 to 45 years
2. Good general health
3. Blood parameters (peptide hormones, clinical chemistry, haematology, Prostate Specific Antigen [PSA]) in normal range
4. Semen parameters in normal range:
4.1. Sperm concentration 20 million/mL
4.2. Sperm morphology greater than 30% normal
4.3. Sperm 50% forwardly motile
5. Couples must be in a stable relationship, dissatisfied with their current method of contraception and have no history of infertility
Female partners:
1. Age of consent to 35 years
2. Regular menstrual cycles
3. No history of Pelvic Inflammatory Disease (PID) in last 12 months
4. Not pregnant
5. Willing to have physical exam and to participate in trial
Previous inclusion criteria:
Male participants:
1. Age 21 to 45 years
2. Good general health
3. Blood parameters (peptide hormones, clinical chemistry, haematology) in normal range
4. Semen parameters in normal range:
a. sperm concentration 20 million/mL
b. sperm morphology greater than 30% normal
c. sperm 50% forwardly motile
Female partners:
1. Age of consent to 35
2. Regularly cycling
3. No history of Pelvic Inflammatory Disease (PID) in last 12 months
4. Not pregnant
5. Willing to have physical exam and to participate in trial
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
40
Participant exclusion criteria
Added 24/09/07:
1. History of active or chronic cardiac, renal, hepatic or prostatic disease or other serious diseases such as diabetes mellitus, hyperlipoproteinemia, etc.
2. Men with active or persistent genitourinary infection
3. Use of medication such as sex steroids or barbiturate
4. Couples in which the wife is breastfeeding
Recruitment start date
01/07/2000
Recruitment end date
01/07/2002
Locations
Countries of recruitment
Indonesia
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
Sponsor details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary