Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
156
Countries
1
Sites
2
Contraception
The main objective of the study is to investigate whether E4+DRSP has a lesser impact on coagulation, measured by endogenous thrombin potential (ETP), than EE+DRSP. We hypothesize that DRSP-only does not significantly alter the in vitro coagulation-related outcomes.
Key facts
- Sponsor
- Pohjois-Pohjanmaan hyvinvointialue, University Of Oulu
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
- Decision date (initial)
- 2026-04-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- National Medical Fund · Oulu University Hospital · University of Oulu · Novo Nordisk Foundation · University of Helsinki · The Finnish Medical Association · Gedeon Richter
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
The main objective of the study is to investigate whether E4+DRSP has a lesser impact on coagulation, measured by endogenous thrombin potential (ETP), than EE+DRSP. We hypothesize that DRSP-only does not significantly alter the in vitro coagulation-related outcomes.
Secondary objectives 5
- Effects on coagulation-related markers: Impact on normalized Activated Protein C resistance ratio (nAPCsr), D-Dimer, and Prothrombin Fragment FI+II levels
- Effects on sex hormone-binding globulin (SHBG)
- Effects on metabolic and inflammatory markers: Lipid and glucose metabolism, low-grade inflammation, and serum proteome
- Effects on ovarian and pituitary hormones: Ovarian steroid hormone and pituitary gonadotrophin secretion
- Effects on adrenal steroid hormones
Conditions and MedDRA coding
Contraception
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Age: 18-40 years when entering the trial
- Willingness to use trial medication and to sign a written informed consent
- BMI: 18-29.9 kg/m2
- PCOS diagnosis according to Rotterdam criteria: clinical or biochemical hyperandrogenism, and/or PCOM, and/or menstrual irregularities.
- Healthy aside from PCOS, no clinically significant illnesses diagnosed by a health care provider, nor any continuous medical treatment
- Two-month withdrawal time from previous use of hormonal contraceptive medication
- Minimum of three months from pregnancy or breastfeeding
- Sufficient knowledge of Finnish to understand research documents and to communicate with research staff
Exclusion criteria 5
- Any contraindication for the use of combined contraceptives
- Clinically significant abnormalities in screening measurements or ultrasound
- Regular smoking/use of nicotine products, illicit drugs, or alcohol abuse
- The aim of becoming pregnant during the study period
- Any disease or condition that may interfere with the conduct of the study or the interpretation of the results
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 6-month use of study preparation, endpoint visit
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Drovelis 3 mg/14.2 mg film-coated tablets
PRD8965736 · Product
- Active substance
- Drospirenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2 DF dosage form
- Max total dose
- 2 DF dosage form
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- G03AA18 — -
- Marketing authorisation
- EU/1/21/1547/001
- MA holder
- GEDEON RICHTER PLC.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Daylette 0,02 mg / 3 mg tabletti, kalvopäällysteinen
PRD6245092 · Product
- Active substance
- Drospirenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2 DF dosage form
- Max total dose
- 2 DF dosage form
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- G03AA12 — DROSPIRENONE AND ESTROGEN
- Marketing authorisation
- 35525
- MA holder
- GEDEON RICHTER PLC.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Slinda 4 mg kalvopäällysteinen tabletti
PRD7756954 · Product
- Active substance
- Drospirenone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2 DF dosage form
- Max total dose
- 2 DF dosage form
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- G03AC10 — -
- Marketing authorisation
- 36346
- MA holder
- EXELTIS HEALTHCARE S.L
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pohjois-Pohjanmaan hyvinvointialue
- Sponsor organisation
- Pohjois-Pohjanmaan hyvinvointialue
- Address
- Kajaanintie 50
- City
- Oulu
- Postcode
- 90220
- Country
- Finland
Scientific contact point
- Organisation
- Pohjois-Pohjanmaan hyvinvointialue
- Contact name
- Pohde Tutkimuspalvelut
Public contact point
- Organisation
- Pohjois-Pohjanmaan hyvinvointialue
- Contact name
- Pohde Tutkimuspalvelut
University Of Oulu
- Sponsor organisation
- University Of Oulu
- Address
- P. O. Box 23
- City
- Oulu
- Postcode
- 90029
- Country
- Finland
Scientific contact point
- Organisation
- University Of Oulu
- Contact name
- Terhi Piltonen
Public contact point
- Organisation
- University Of Oulu
- Contact name
- Tutkimushoitaja Oulu
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 156 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol_CoCo3-PCOS_for-publication | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CoCo3-PCOS | 1.1 |
| Recruitment arrangements (for publication) | K1_rekrytointi-ja-suostumusprosessi_ CoCo3-PCOS | 1.1 |
| Recruitment arrangements (for publication) | K2_mainos_painettava_CoCo3 | 1.1 |
| Recruitment arrangements (for publication) | K2_mainos_some_Coco3 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-and-ICF_CoCo3-PCOS_Public | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Daylette_eng | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Daylette_fi-sv | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Drovelis_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Drovelis_fi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Drovelis_sv | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Slinda_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Slinda_fi-sv | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-22 | Finland | Acceptable 2026-04-10
|
2026-04-20 |