Progesterone for Breast Development in Trans Wome
- Conditions
- <p>Hormone treatment to induce breast development in trans women</p>
- Registration Number
- NL-OMON21386
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 90
Trans woman
- 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
-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 micronized progesterone (Utro-gestan): Known, past or suspected breast cancer; Known or suspected estrogen-dependent malignant tumours (e.g genital tract carcinoma); Thrombophlebitis; Previous or current thromboembolism disorders (e.g. deep venous thrombosis, pul-monary embolism); Known thrombophilic disorders; Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal (<2.5xULN); Known hypersensitivity to the active substances or to any of the excipients (Sunflower oil, Soya lecithin, Gelatin, Glycerol, Titanium dioxide); Porphyria; Cerebral hemor-rhage. Interfering medication (SPC).
-Mental health issues that prevent participation
-History of epilepsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters include change in breast size as determined by measurement of breast volume and determination of the bra cup size.</p>
- Secondary Outcome Measures
Name Time Method <p>Serum progesterone levels, patient satisfaction, mood changes, sleep quality, and adverse events are secondary endpoints.</p>