Clinical trial • Not applicable • Other
Drospirenone, Estetrol for Contraception
Not applicable trial of Drospirenone, Estetrol for Contraception.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Contraception
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-12-2025
- First CTIS Authorization Date
- 17-04-2026
Trial design
Randomised, open-label, comparator: slinda 4 mg film-coated tablet (drospirenone) — oral. other arms: drovelis 3 mg/14.2 mg film-coated tablets (drospirenone + estetrol) — oral; daylette 0,02 mg / 3 mg film-coated tablet (ethinylestradiol + drospirenone) — oral. detailed dosing schedule not specified in ctis metadata.-controlled Not applicable trial across 2 sites in Finland.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Comparator: Slinda 4 mg film-coated tablet (drospirenone) — oral. Other arms: Drovelis 3 mg/14.2 mg film-coated tablets (drospirenone + estetrol) — oral; Daylette 0,02 mg / 3 mg film-coated tablet (ethinylestradiol + drospirenone) — oral. Detailed dosing schedule not specified in CTIS metadata.
- Target Sample Size
- 156
- Trial Duration For Participant
- 365
Eligibility
Recruits 156 Vulnerable population not selected; participants must sign written informed consent; sufficient knowledge of Finnish is required to understand research documents and to communicate with research staff; subject information and informed consent form (L1_SIS-and-ICF_CoCo3_Public) submitted..
- Pregnancy Exclusion
- The aim of becoming pregnant during the study period
- Vulnerable Population
- Vulnerable population not selected; participants must sign written informed consent; sufficient knowledge of Finnish is required to understand research documents and to communicate with research staff; subject information and informed consent form (L1_SIS-and-ICF_CoCo3_Public) submitted.
Inclusion criteria
- {"criterion_text":"- Age: 18-40 years when entering the trial"}
- {"criterion_text":"- Willingness to use trial medication and to sign a written informed consent"}
- {"criterion_text":"- BMI: 18-29.9 kg/m2"}
- {"criterion_text":"- Healthy, no clinically significant illnesses diagnosed by a health care provider, nor any continuous medical treatment"}
- {"criterion_text":"- Regular menstrual cycle"}
- {"criterion_text":"- Two-month withdrawal time from previous use of hormonal contraceptive medication"}
- {"criterion_text":"- Minimum of three months from pregnancy or breastfeeding"}
- {"criterion_text":"- Sufficient knowledge of Finnish to understand research documents and to communicate with research staff"}
Exclusion criteria
- {"criterion_text":"- Any contraindication for the use of combined contraceptives"}
- {"criterion_text":"- Clinically significant abnormalities in screening measurements or ultrasound"}
- {"criterion_text":"- Regular smoking/use of nicotine products, illicit drugs, or alcohol abuse"}
- {"criterion_text":"- The aim of becoming pregnant during the study period"}
- {"criterion_text":"- Any disease or condition that may interfere with the conduct of the study or the interpretation of the results"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 12-month use of study preparation, endpoint visit","definition_or_measurement_approach":"Measured as use of study preparation assessed at the 12-month endpoint visit."}
Recruitment
- Digital Remote Recruitment
- True, advertising materials for social media are included among submitted recruitment documents (K2_mainos_some_Coco3).
- Planned Sample Size
- 156
- Recruitment Window Months
- 42
- Consent Approach
- Participants must sign written informed consent; sufficient knowledge of Finnish is required to understand research documents and to communicate with research staff; a subject information and informed consent form (L1_SIS-and-ICF_CoCo3_Public) was submitted.
Methods
- Recruitment arrangements document submitted (K1_Recruitment-arrangements_CoCo3).
- Advertising materials for print (K2_mainos_painettava_CoCo3) and social media (K2_mainos_some_Coco3) provided (documents listed in CTIS).
- Target audience specified in protocol metadata: healthy female volunteers aged 18-40 years in Finland.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 156
Finland
- Earliest CTIS Part Ii Submission Date
- 16-03-2026
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 32
- Number Of Sites
- 2
- Number Of Participants
- 156
Sites
- Site Name
- Oulu University Hospital
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- Terhi Piltonen
- Principal Investigator Email
- coco3tutkimus@pohde.fi
- Contact Person Name
- Pohde tutkimuspalvelut
- Contact Person Email
- coco3tutkimus@pohde.fi
- Site Name
- HUS-yhtymae
- Department Name
- Obstetrics & Gynecology
- Principal Investigator Name
- Kaisu Luiro-Helve
- Principal Investigator Email
- coco3tutkimus@hus.fi
- Contact Person Name
- Kaisu Luiro-Helve
- Contact Person Email
- coco3tutkimus@hus.fi
Sponsor
Primary sponsor
- Full Name
- Pohjois-Pohjanmaan hyvinvointialue
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Third parties
- {"country":"","full_name":"University of Oulu","duties_or_roles":"Source of monetary support","organisation_type":""}
- {"country":"","full_name":"National Medical Fund","duties_or_roles":"Source of monetary support","organisation_type":""}
- {"country":"","full_name":"Gedeon Richter","duties_or_roles":"Source of monetary support","organisation_type":""}
- {"country":"","full_name":"Orion Research Foundation","duties_or_roles":"Source of monetary support","organisation_type":""}
- {"country":"","full_name":"University of Helsinki","duties_or_roles":"Source of monetary support","organisation_type":""}
- {"country":"","full_name":"Novo Nordisk Foundation","duties_or_roles":"Source of monetary support","organisation_type":""}
- {"country":"","full_name":"The Finnish Medical Association","duties_or_roles":"Source of monetary support","organisation_type":""}
- {"country":"","full_name":"Oulu University Hospital","duties_or_roles":"Source of monetary support","organisation_type":""}
Co-sponsors
- University Of Oulu
Investigational products
- Investigational Product Name
- Drovelis 3 mg/14.2 mg film-coated tablets
- Active Substance
- Drospirenone, Estetrol
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 2 DF dosage form (maxDailyDoseAmount 2)
- Investigational Product Name
- Daylette 0,02 mg / 3 mg tabletti, kalvopäällysteinen
- Active Substance
- Drospirenone, Ethinylestradiol
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 2 DF dosage form (maxDailyDoseAmount 2)
- Investigational Product Name
- Slinda 4 mg kalvopäällysteinen tabletti
- Active Substance
- Drospirenone
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 8 mg (maxDailyDoseAmount 8)
- Combination Treatment
- Yes
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