Administration of testosterone to women with androgen insensitivity: a study of the role of androgen replacement on psychological function
| ISRCTN | ISRCTN17551969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17551969 |
| Protocol serial number | N0263082995 |
| Sponsor | Department of Health (UK) |
| Funder | University College London Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 13/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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 GS Conway
Scientific
Scientific
University College Hospital
235 Euston Rd
Fitzrovia
London
NW1 2BU
United Kingdom
| Phone | +44 20 3447 9101 |
|---|---|
| endocrine.dept@uclh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Administration of testosterone to women with androgen insensitivity: a study of the role of androgen replacement on psychological function |
| Study objectives | To assess the advantages of testosterone replacement over androgen replacement in women with androgen insensitivity. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Androgen replacement |
| Intervention | Randomised controlled trial: 1. Placebo 2. Testosterone |
| Intervention type | Other |
| Primary outcome measure(s) |
Standardised psychological questionnaires. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 20 |
| Key inclusion criteria | 20 Patients from Endocrinology. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/06/2000 |
| Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Endocrinology
Cobbold Laboratories, 7th Floor
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/10/2017: No publications found in PubMed, verifying study status with principal investigator.
