To explore the effects on breast development of addition of progesterone to the treatment with estradiol in trans women after vaginoplasty or orchiectomy. Secondary objectives include safety and patient satisfaction, mood, and sleep.
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters include change in breast size as determined by
measurement of breast volume and determination of the bra cup size.
Secondary outcome
Serum progesterone levels, patient satisfaction, mood changes, sleep quality,
and adverse events are secondary endpoints.
Background summary
Trans women (male sex assigned at birth, female gender identity) receive
hormone therapy in order to induce secondary female sex characteristics.
Traditionally, this hormone therapy includes estradiol and anti-androgenic
treatment. Research has demonstrated that breast de-velopment in trans women is
often limited and as a result trans women may choose to un-dergo breast
augmentation surgery. Progesterone is important for breast development in cis
women (female sex assigned at birth, female gender identity) during puberty. A
potential role for progesterone with regard to breast development in trans
women has not been investigated in a controlled experimental set up.
Study 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 objectives include safety and patient satisfaction, mood, and sleep.
Study design
This is a non-blinded, non-placebo, randomized controlled pilot trial using a
factorial design.
Intervention
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 baseline dose of estradiol and
progesterone 200 mg daily, group C receive the baseline dose of estradiol and
progesterone 400 mg daily, group D will receive twice the baseline dose of
estradiol, group E will receive twice the baseline dose of estradiol and
progesterone 200 mg daily and group F will receive twice the baseline dose of
estradiol and progesterone 400 mg daily.
Study burden and risks
Participation in the study will include 4 visits to the clinic, at baseline
(visit 1) and after 3, 6, and 12 months (visits 2,3,4). During visits 1-4,
measurement of breast-chest circumference difference and volume measurement
will be performed using breast 3D imaging. Participants will be asked to fill
out questionnaires at visits 1-4. At visits 1, 3, and 4, blood samples will be
taken. During the study, participants will continue their regular visits to the
gender clinic. We estimate that the risks associated with the investigational
treatment will be limited. Increased doses of estradiol may lead to breast
pain, headache or weight gain. The most common side effect of progesterone is
headache. Uncommon and rare side effects include breast pain, drowsiness,
nausea, diarrhea, constipation, jaundice, pruritus, and acne. Increased risks
of breast cancer, thromboembolic events, coronary artery disease, and ischemic
stroke have been reported for progesterone-like compounds, but for not
progesterone itself, when used in combination with estradiol.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-001952-16-NL |
| CCMO | NL73840.029.20 |
| OMON | NL-OMON21386 |