Condition category
Pregnancy and Childbirth
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
07/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.who.int/reproductive-health/hrp/

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

Publication citations

Additional files

Editorial Notes