Progesterone for Breast Development in Trans Women; Assessment of effects and safety -a pilot trial

Phase 2

Recruiting

• Conditions: gender affirming hormone treatment; Hypogonadism; 10014701; 10074469

• Registration Number: NL-OMON49293
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 90

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

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<br /><br>measurement of breast volume and determination of the bra cup size. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Serum progesterone levels, patient satisfaction, mood changes, sleep quality,<br /><br>and adverse events are secondary endpoints. </p><br>