Krasean 2019.

Study name	Anti‐androgenic effects comparison between cyproterone acetate and spironolactone in transgender women: a randomised controlled trial (Trial ID: TCTR20190404001)
Methods	Allocation: randomised Study design: randomised controlled trial Control: active Study endpoint classification: efficacy study Intervention model: Parallel Number of arms: 2 Masking: double blind (Masked roles: participant caregiver, investigator) Primary purpose: treatment Study phase: phase 4
Participants	Gender: male Age limit: minimum 18 years: maximum 40 years Condition: Gender dysphoria patients diagnosed from DSM V Male to female transgender Not undergone orchidectomy No psychological disease or mental disability
Interventions	Arm 1: Intervention name: cyproterone acetate Type: active comparator Classification: drug Descriptions: participants (gender dysphoria patients) will receive estradiol valerate (4 mg daily) combined with cyproterone acetate (25 mg daily) for cross‐sex hormone treatment. Arm: 2 Intervention name: spironolactone Type: experimental Classification: drug Descriptions: participants (gender dysphoria patients) will be received estradiol valerate (4 mg daily) combined with spironolactone (100 mg daily) for cross‐sex hormone treatment.
Outcomes	Primary outcome(s): Outcome name: testosterone level Measurement: Electrochemiluminescent Immunoassay (ECLIA) of total testosterone level Time point: three months after intervention Safety issue: no Key secondary outcomes: Outcome name: physical and metabolic changes Measurement: physical examination, metabolic profile parameters Time point: three months after intervention Safety Issue: no
Starting date	April 3, 2019 (estimated end date: June 16, 2020)
Contact information	Contact: Krasean Panyakhamlerd Degree: Assoc. Prof. Phone: 0926536415 Email: krasean@hotmail.com Postal Address: 1873 Rama 4 Road, Patumwan State/Province: Bangkok Postal Code: 10400 Country: Thailand
Notes	Source(s) of monetary or material supports: Ratchadapisek Sompoch Fund, Faculty of Medicine, Chulalongkorn University Declarations of interest not reported