Condition category
Pregnancy and Childbirth
Date applied
22/03/2004
Date assigned
01/04/2004
Last edited
20/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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
CH-1211
Switzerland
vogelsongk@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HRP ID A15242

Study information

Scientific title

Acronym

Study hypothesis

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Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Male contraception

Intervention

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)

Intervention type

Drug

Phase

Phase II

Drug names

Testosterone undecanoate (TU), depomedroxyprogesterone acetate (DMPA)

Primary outcome measures

1. Changes in sperm concentrations to azoospermia or severe oligozoospermia at 24 weeks
2. Time to suppress spermatogenesis at 24 weeks

Secondary outcome measures

Suppression of gonadotropins and maintenance of normal blood testosterone levels at 24 weeks.

Overall trial start date

01/06/2003

Overall trial end date

01/06/2004

Reason abandoned

Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory.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 inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

64

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/06/2003

Recruitment end date

01/06/2004

Locations

Countries of recruitment

China, India, Indonesia

Trial participating centre

World Health Organization
Geneva
CH-1211
Switzerland

Sponsor information

Organisation

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

Sponsor details

World Health Organization
20 Avenue Appia
Geneva
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