Does progesterone treatment of trans women lead to increased breast development and are there side effects? A pilot trial.
- Conditions
- Hormone treatment of transgender women, we will investigate whether addition of progesterone to estradiol treatment results in an increase of breast volume and if there are side effects.Therapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2020-001952-16-NL
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 90
-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-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 (<2.5xULN); Known hy-persensitivity to the active substances or to any of the excipients (Sunflower oil, Soya lecithin, Gelatin, Glycerol, Titanium dioxide); Porphyria; Cerebral hemorrhage.
-Mental health issues that prevent participation
-History of epilepsy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To explore the effects on breast development of addition of progesterone to the treatment with estradiol in trans women after vaginoplasty or orchiectomy. ;Secondary Objective: Secondary objectives include safety and patient satisfaction, mood, sleep and sexuality. ;Primary end point(s): The main study end point is breast development over the duration of this study. For this purpose, 3D breast images and breast-chest circumference differences will be measured (centimeters). 3D imaging of the breasts will be carried out using an Artec LEO 3D scanner in order to determine breast volume. Bra cup sizes can be calculated from breast-chest circumference differences measurements and the 3D images.;Timepoint(s) of evaluation of this end point: 3, 6, 12 months
- Secondary Outcome Measures
Name Time Method