| CTRI Number |
CTRI/2023/05/052920 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF TESTOSTERONE HORMONAL THERAPY IN GENERAL WELL-BEING OF TRANSMALE (FEMALE TO MALE)INDIVIDUALS |
|
Scientific Title of Study
|
GENDER AFFIRMING CROSS-SEX HORMONAL THERAPY IN TRANSMALES- A COMPARATIVE STUDY USING TWO DIFFERENT TESTOSTERONE FORMULATIONS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sinju Sankar P |
| Designation |
DM postgraduate of Endocrinology Madurai Medical College |
| Affiliation |
Madurai Medical College |
| Address |
Government Rajaji Hospital Madurai Medical College
Panagal road Madurai 625020
Madurai
TAMIL NADU
625020
India |
| Phone |
9995632286 |
| Fax |
|
| Email |
sankar.sinju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sridhar |
| Designation |
Professor and Head od the department of Endocrinology Madurai medical college |
| Affiliation |
Madurai Medical College |
| Address |
Government Rajaji Hospital Madurai Medical College
Panagal road Madurai 625020
Madurai
TAMIL NADU
625020
India |
| Phone |
9995632286 |
| Fax |
|
| Email |
drsridharjipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sinju Sankar P |
| Designation |
DM postgraduate of Endocrinology Madurai Medical College |
| Affiliation |
Madurai Medical College |
| Address |
Government Rajaji Hospital Madurai Medical College
Panagal road Madurai 625020
Madurai
TAMIL NADU
625020
India |
| Phone |
9995632286 |
| Fax |
|
| Email |
sankar.sinju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Rajaji Hospital, Madurai Medical College |
|
|
Primary Sponsor
|
| Name |
Government Rajaji hospital |
| Address |
Government Rajaji Hospital Madurai Medical College
Panagal road Madurai 625020 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sinju Sankar P |
Government Rajaji hospital Madurai |
Government Rajaji Hospital
OP No-4 ; Madurai Medical College
Panagal road Madurai 625020
Madurai
TAMIL NADU |
09995632286
sankar.sinju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MADURAI MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adults with gender dysphoria |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Testosterone |
Two different formulations of Testosterone- testovirion (100/250mg) intramuscularly once in 3 weeks or Testosterone undeconate 1000mg given intramuscularly once in 3 months for 1 year |
| Comparator Agent |
Not applicable |
Only intervention not comparison |
| Intervention |
TESTOSTERONE |
Testosterone undeconate 1000mg given intramuscularly once in 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Adult females with gender dysphoria
Treatment naïve transmales |
|
| ExclusionCriteria |
| Details |
Patients who are already on testosterone therapy
Age less than 18 years with gender dysphoria
Patients with comorbid conditions like hypertension, diabetes, cardiovascular disease
Patients on Calcium/ Vitamin D / bisphosphonates
Contraindications to testosterone therapy
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Alleviation of gender dysphoria
Increase in facial hair, body hair, clitoromegaly
Increase in lean body mass, decrease in fat mass
Increase in bone mineral density
Increase in testosterone levels
|
at baseline, 6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare two different formulations of testosterone in getting the desired outcomes |
at baseline, 6 months and 1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2023 |
| Date of Study Completion (India) |
01/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Adults with gender dysphoria will be recruited for the stuay. After confirming gender dysphoria, basic lab investigations like complete blood count, liver function test, fasting lipid profile , hormonal profile including TSH,LH,FSH, Testosterone,Estradiol,Prolactin and Bone mineral density, lean muscle mass, fat mass using DEXA will be taken at baseline and patient will be assessed for gender dysphoria and quality of life using GPSQ and RAND questionnaire at baseline . Patient will be started on testosterone injections using two different formulations, either Testovirion(100 mg/250 mg) or Testosterone undeconate (1000 mg ) based on block randomisation. Patients are then re-evaluated after 1 year for the changes expected to occur. Patient will be assessed clinically for the changes and also biochemically .and all the investigations are repeated including DEXA. |