E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
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. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To explore the effects on breast development of addition of progesterone to the treatment with estradiol in trans women after vaginoplasty or orchiectomy. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include safety and patient satisfaction, mood, sleep and sexuality. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
One secondary study end point is patient satisfaction, this will be assessed at the start of the intervention and during the follow-up visits by three questionnaires: the Rosenberg self-esteem scale (Rosenberg, 1979), the Breast Satisfaction Rating Scale (BSRS), and a non-validated satisfaction questionnaire about different aspects of the breasts. Satisfaction will be measured with regard to different aspects such as symmetry of the breast, the breast volume, and size and shape of the nipple. In addition, ad-verse and serious adverse effects will be recorded. Further, mood and sleep quality will be assessed using the Perceived stress scale, Inventory of Depressive Symptomatology, self-report (IDS-SR), Pittsburgh Sleep Quality Index (PSQI) questionnaires, which have been adapted for the Castor data-management system. Additionally, the levels of experienced sexual pleasure will be assessed using the Amsterdam Sexual Pleasure Index state Vol 1.0 (ASPI) which has been adapted for the Castor data-management system. Filling in the ASPI is optional. Serum progesterone concentrations will be measured after 6 and 12 months.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 6 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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After all subjects have completed 12 months of the investigational treatment. In case of serious side effects the trial will be stopped prematurely. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |