EFFECT OF TESTOSTERONE HORMONAL THERAPY IN GENERAL WELL-BEING OF TRANSMALE (FEMALE TO MALE)INDIVIDUALS

Completed

Conditions: Adults with gender dysphoria

Registration Number: CTRI/2023/05/052920

Lead Sponsor: Government Rajaji hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Adult females with gender dysphoria Treatment naÃ¯ve transmales.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in bone mineral density	at baseline, 6 months and 1 year
Increase in testosterone levels	at baseline, 6 months and 1 year
Alleviation of gender dysphoria	at baseline, 6 months and 1 year
Increase in facial hair, body hair, clitoromegaly	at baseline, 6 months and 1 year
Increase in lean body mass, decrease in fat mass	at baseline, 6 months and 1 year

Secondary Outcome Measures

Name	Time	Method
To compare two different formulations of testosterone in getting the desired outcomes	at baseline, 6 months and 1 year

Trial Locations

Locations (1): Government Rajaji hospital Madurai
🇮🇳
Madurai, TAMIL NADU, India
Government Rajaji hospital Madurai
🇮🇳Madurai, TAMIL NADU, India
Dr Sinju Sankar P
Principal investigator
09995632286
sankar.sinju@gmail.com