Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
20/08/2015
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 GS Conway

ORCID ID

Contact details

University College Hospital
235 Euston Rd
Fitzrovia
London
NW1 2BU
United Kingdom
+44 20 3447 9101
endocrine.dept@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263082995

Study information

Scientific title

Administration of testosterone to women with androgen insensitivity: a study of the role of androgen replacement on psychological function

Acronym

Study hypothesis

To assess the advantages of testosterone replacement over androgen replacement in women with androgen insensitivity.

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Androgen replacement

Intervention

Randomised controlled trial:
1. Placebo
2. Testosterone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Standardised psychological questionnaires.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2000

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

20 Patients from Endocrinology.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/06/2000

Recruitment end date

01/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Endocrinology
Cobbold Laboratories, 7th Floor The Middlesex Hospital Mortimer Street
London
W1N 8AA
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

University College London Hospitals NHS Trust (UK)

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