The effect of Testosterone Undecanoate (TU) alone or combined with Depot Medroxyprogesterone Acetate (DMPA) on sperm production of Indonesian fertile men

ISRCTN	ISRCTN80724703
DOI	https://doi.org/10.1186/ISRCTN80724703
Secondary identifying numbers	WHO/HRP ID A05082

Submission date: 19/03/2004
Registration date: 01/04/2004
Last edited: 07/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
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-27
CH-1211
Switzerland

Email	vogelsongk@who.int

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Testosterone Undecanoate (TU), Depot Medroxyprogesterone Acetate (DMPA)
Primary outcome measure	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 study start date	01/07/2000
Completion date	01/07/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	40
Key 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
Key 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
Date of first enrolment	01/07/2000
Date of final enrolment	01/07/2002

Locations

Countries of recruitment

Indonesia
Switzerland

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Sponsor information

UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
Research organisation

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Website	http://www.who.int/reproductive-health/hrp/
"ROR"	https://ror.org/01f80g185

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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan