Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/03/2004
Date assigned
01/04/2004
Last edited
10/10/2014
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 A25166

Study information

Scientific title

Acronym

Study hypothesis

1. Describe the Pharmacokinetic (PK) profile of a new formulation of Testosterone Undecanoate (TU) (250 mg/ml in soy bean oil); and
2. Compare two doses of this formulation of TU with a single dose of formulations that are currently being evaluated in clinical trials

Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the World Health Organization (WHO) directory.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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hypogonadism

Intervention

Study participants will be randomised to receive a single administration (injection) of one of the following:
1. 500 mg of the novel TU formulation
2. 1000 mg of the novel TU formulation
3. 1000 mg of 125 mg/ml TU in tea seed oil
4. 1000 mg of 250 mg/ml TU in caster oil.

Intervention type

Drug

Phase

Not Applicable

Drug names

Testosterone undecanoate

Primary outcome measures

1. Circulating concentrations of testosterone at 12 weeks
2. Profile of testosterone concentrations over time at 12 weeks
3. Gonadotropin concentrations at 12 weeks

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/1997

Overall trial end date

01/01/1999

Reason abandoned

Due to funding limitations and focus on an alternative intervention, the study was never initiated and has been withdrawn from the directory.

Eligibility

Participant inclusion criteria

1. Male participants age 18 to 50 years
2. Diagnosed with hypogonadism (androgen values below the normal range for the centre)
3. Not concurrently undergoing other androgen therapy

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

72

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/01/1997

Recruitment end date

01/01/1999

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 (HRP)

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

Funder name

Test compounds donated by manufacturer (Xianju Pharmaceutical Corporation, Zhejiang, People's Republic of China).

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