The safety of finasteride for female-to-male (FTM) transgender patients

JRCT ID: jRCTs061210040

Registered date:07/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Female-to-male (FTM) transgender
• Date of first enrollment: 05/01/2022
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Finasteride 0.2 mg are orally administered once daily for 3 months. If patients are able to received the drug safely after 3 months, the dosage is increased to 1.0 mg and they are observed for an additional 3 months.

Outcome(s)

• Primary Outcome: Treatment-related adverse events at 1 week, 1 month, and 3 months from the start of administration, and percentage of patients who could continue treatment at 3 months

Secondary Outcome

(1) Treatment effect (evaluation of improvement from baseline using photographs of the parietal area using the Norwood-Hamilton classification)
(2) Blood examination (CBC, AST, ALT, ALP, gamma- GTP, T-Bil, BUN, Cr, UA, estradiol, testosterone, T.Cho, HDL-C, LDL-C, TG, LH, FSH, D-dimer)
(3) Physical examination (weight, BMI, body fat percentage, muscle mass)
(4) Subjective symptoms (cessation of menstruation, change in acne)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

(1) Patients diagnosed with female-to-male (FTM) transgender who are 20 years of age or older and younger than 60 years at the time of obtaining consent
(2) Receiving testosterone replacement therapy in our department.
(3) Have androgenetic alopecia (II or higher in the Modified Norwood-Hamilton Classification)
(4) Provide sufficient informed consent to participate in the study, and get his or her voluntary written consent.

Exclude criteria

(1) History of allergy, which is associated with finasteride.
(2) Liver dysfunction.
(3) Post-sex reassignment surgery.
(4) Severe mental disorders (e.g., severe depression).
(5) Inappropriate for enrollement decided by the attending physician.

Related Information

• Primary Sponsor: Tominaga Yusuke