Progesterone for Breast Development in Trans Women

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21386

Enrollment

Registered

2020-12-02

Start date

2021-01-03

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone treatment to induce breast development in trans women

Interventions

Addition of progesterone to the treatment with estradiol in trans women after vaginoplasty or orchiectomy

Eligibility

Inclusion criteria

Inclusion criteria: - 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

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 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

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.	—

Contacts

Public ContactKoen Dreijerink

Amsterdam UMC, location VUmc

k.dreijerink@amsterdamumc.nl020-4444444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)