gender affirming hormone treatment Hypogonadism
Conditions
Interventions
Participants will be randomized into six groups of 15 subjects each (A-F). For
12 months, group A will continue to receive the baseline dose of estradiol
(control group), group B will receive the ba
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Start of hormone treatment after 18 years of age - More than one year of hormone treatment - Underwent vaginoplasty or orchiectomy - Sufficient knowledge of the Dutch language - BMI 18-30 kg/m2
Exclusion criteria
Exclusion criteria: - No regular follow-up visits at the clinic for gender dysphoria - Previous use of progesterone/ progestin (not including cyproterone acetate) - History of breast augmentation or reduction surgery - Active treatment for depression - Current use of progesterone/ progestin including cyproterone acetate (e.g. because of increased bodily hair growth after vaginoplasty) - Severe familial dyslipidemia (e.g. Familial Hypercholesterolemia) - Serum estradiol concentration > VUmc reference range (150-400 pmol/L) at last visit prior to baseline - Any of the following contraindications for the use of progesterone (Utrogestan): Known, past or suspected breast cancer; Known or suspected estrogen-dependent malignant tumours (e.g genital tract carcinoma); Thrombophlebitis; Previous or cur-rent thromboembolism disorders (e.g. deep venous thrombosis, pulmonary embo-lism); Known thrombophilic disorders; Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters include change in breast size as determined by measurement of breast volume and determination of the bra cup size. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum progesterone levels, patient satisfaction, mood changes, sleep quality, and adverse events are secondary endpoints. | — |
Countries
Netherlands
Outcome results
None listed