Clinical trial • Phase IV • Endocrinology | Cardiology
Estradiol for Turner syndrome
Phase IV trial of Estradiol for Turner syndrome.
Overview
- Trial Therapeutic Area
- Endocrinology | Cardiology
- Trial Disease
- Turner syndrome
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 01-10-2024
- First CTIS Authorization Date
- 23-10-2024
Trial design
Estrofem (oral estradiol) versus Divigel 1 mg gel (transdermal estradiol); specific doses/schedules not specified in the record-controlled Phase IV trial across 1 site in Denmark.
- Comparator
- Estrofem (oral estradiol) versus Divigel 1 mg gel (transdermal estradiol); specific doses/schedules not specified in the record
- Target Sample Size
- 50
Eligibility
Recruits 50 No vulnerable population selected; participants are adults aged 18-50. Consent obtained from adult participants; assent/parental consent not applicable..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- No vulnerable population selected; participants are adults aged 18-50. Consent obtained from adult participants; assent/parental consent not applicable.
Inclusion criteria
- {"criterion_text":"- Diagnosis of Turner syndrome regardless of karyotype (Turner syndrome)\n- Age 18-50 years (Turner syndrome and healthy controls)\n- Already receiving estrogen treatment (Turner syndrome)\n- Female (healthy controls)\n- Previously healthy (healthy controls)\n- Not receiving any medication (healthy controls)\n- Not using any kind of contraceptive pills (healthy controls)\n- No mental or psychiatric disorders (healthy controls)"}
Exclusion criteria
- {"criterion_text":"- Active systemic chronic diseases\n- Known or suspected breast cancer\n- Known or suspected estradiol-dependent tumors (endometrial cancer or similar)\n- Untreated endometrial hyperplasia\n- Current or previous venous thromboembolism\n- Acute or previous liver disease where liver enzymes are still elevated by a factor 3 or more\n- Known hypersensitivity to the medications used\n- Pregnancy\n- Menopause (healthy controls only)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Equipotency: Levels of luthenizing hormone and follicle stimulating hormone are measured at different doses","definition_or_measurement_approach":"Levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) measured at different estradiol doses to determine equipotency (using estradiol-dependent surrogate markers)."}
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 59
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent forms are listed (documents L1_SIS, L1_ICF, L1_ICF_biobank). No assent or parental consent required. Documents include Danish translations.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 50
Denmark
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 23-10-2024
- Processing Time Days
- 6
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Department of Endocrinology and Internal Medicine, Aarhus University Hospital
- Department Name
- Endocrinology and Internal Medicine
- Contact Person Name
- Camilla Mains Balle
- Contact Person Email
- camibl@clin.au.dk
Sponsor
Primary sponsor
- Full Name
- Region Midtjylland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"Sponsor duty code 1","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- Estrofem, filmovertrukne tabletter
- Active Substance
- Estradiol
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation number 06697)
- Maximum Dose
- 10 mg per day (max total 140 mg)
- Investigational Product Name
- Divigel 1 mg gel
- Active Substance
- Estradiol
- Modality
- Small molecule
- Routes Of Administration
- Transdermal
- Route
- Transdermal
- Authorisation Status
- Authorised (marketing authorisation number 13296)
- Maximum Dose
- 10 mg per day (max total 140 mg)
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