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    Summary
    EudraCT Number:2020-001952-16
    Sponsor's Protocol Code Number:PTW-1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-001952-16
    A.3Full title of the trial
    Progesterone for Breast Development in Trans Women; Assessment of effects and safety -a pilot trial-
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does progesterone treatment of trans women lead to increased breast development and are there side effects? A pilot trial.
    A.3.2Name or abbreviated title of the trial where available
    Progesterone in Trans Women
    A.4.1Sponsor's protocol code numberPTW-1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmsterdam UMC, location VUmc
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBesins Healthcare
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, location VUmc
    B.5.2Functional name of contact pointProject contact
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31204445560
    B.5.5Fax number31204440505
    B.5.6E-mailk.dreijerink@amsterdamumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Utrogestan
    D.2.1.1.2Name of the Marketing Authorisation holderBesins Healthcare Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical 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.
    E.1.1.1Medical 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.
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Secondary objectives include safety and patient satisfaction, mood, sleep and sexuality.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3, 6, 12 months
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 12 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No progesterone
    E.8.2.4Number of treatment arms in the trial6
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    After all subjects have completed 12 months of the investigational treatment. In case of serious side effects the trial will be stopped prematurely.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None, regular care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-26
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