Clinical trial • Phase IV • Other
MEDROXYPROGESTERONE ACETATE for Female infertility
Phase IV trial of MEDROXYPROGESTERONE ACETATE for Female infertility.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Female infertility
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 29-11-2023
- First CTIS Authorization Date
- 11-03-2024
Trial design
GANIRELIX — comparator product listed; reported max daily dose 0.25 mg, max total dose 2.75 mg; route: subcutaneous injection-controlled Phase IV trial across 2 sites in Spain.
- Comparator
- GANIRELIX — comparator product listed; reported max daily dose 0.25 mg, max total dose 2.75 mg; route: subcutaneous injection
- Target Sample Size
- 144
Eligibility
Recruits 144 No vulnerable populations selected; consent: 'Give and sign consent to participate in the study.'.
- Vulnerable Population
- No vulnerable populations selected; consent: 'Give and sign consent to participate in the study.'
Inclusion criteria
- {"criterion_text":"- 1.\tAge less than 43 years .\n- 2.\tRegular menstrual cycles between 21 and 35 days.\n- 3.\tIndication for IVF with PGT-A\n- 4. Both ovaries present.\n- 5. Ability to participate and complete the study.\n- 6. Give and sign consent to participate in the study."}
Exclusion criteria
- {"criterion_text":"- 1.\tEndometriosis grade III/IV\n- 2.\tConcurrent participation in another study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- number of euploid embryos","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 144
- Recruitment Window Months
- 14
- Consent Approach
- Participants must 'Give and sign consent to participate in the study.' No assent procedures or consent languages are specified.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 144
Spain
- Earliest CTIS Part Ii Submission Date
- 11-10-2023
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 152
- Number Of Sites
- 2
- Number Of Participants
- 144
Sites
- Site Name
- Gran Via de les Corts Catalanes, 456
- Department Name
- Medicina Reproductiva
- Contact Person Name
- Claudia Blancafort
- Contact Person Email
- c.blancafort@ginefiv.com
- Site Name
- Calle Jose Silva 18
- Department Name
- Medicina Reproductiva
- Contact Person Name
- Claudia Blancafort
- Contact Person Email
- c.blancafort@ginefiv.com
Sponsor
Primary sponsor
- Full Name
- Ginefiv S.L.
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Third parties
- {"country":"","full_name":"Theramex","duties_or_roles":"Source of monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Progevera 10 mg comprimidos
- Active Substance
- MEDROXYPROGESTERONE ACETATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation number 59.139, ES)
- Starting Dose
- 10 mg (max daily dose reported 10 mg)
- Maximum Dose
- 140 mg (maxTotalDoseAmount 140)
- Investigational Product Name
- GANIRELIX
- Active Substance
- GANIRELIX
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Marketing authorisation number not provided
- Starting Dose
- 0.25 mg (max daily dose reported 0.25 mg)
- Maximum Dose
- 2.75 mg (maxTotalDoseAmount 2.75)
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