Clinical trial • Not applicable • Endocrinology

Drospirenone; Estetrol for Polycystic ovary syndrome | Contraception

Not applicable trial of Drospirenone; Estetrol for Polycystic ovary syndrome | Contraception.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Polycystic ovary syndrome | Contraception
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-12-2025
First CTIS Authorization Date
20-04-2026

Trial design

Randomised, open-label, slinda 4 mg film-coated tablet (drospirenone 4 mg) — comparator arm (oral). other arms include drovelis 3 mg/14.2 mg film-coated tablets (drospirenone + estetrol) and daylette 0.02 mg / 3 mg film-coated tablet (ethinylestradiol + drospirenone) as test arms.-controlled Not applicable trial across 2 sites in Finland.

Randomised
Yes
Open Label
Yes
Comparator
Slinda 4 mg film-coated tablet (drospirenone 4 mg) — comparator arm (oral). Other arms include Drovelis 3 mg/14.2 mg film-coated tablets (drospirenone + estetrol) and Daylette 0.02 mg / 3 mg film-coated tablet (ethinylestradiol + drospirenone) as test arms.
Target Sample Size
156
Trial Duration For Participant
180

Eligibility

Recruits 156 No vulnerable populations selected. Participants are adult women aged 18-40. Written informed consent is required from each participant (inclusion: "Willingness to use trial medication and to sign a written informed consent"); sufficient knowledge of Finnish is required. No assent procedures are indicated..

Pregnancy Exclusion
The aim of becoming pregnant during the study period
Vulnerable Population
No vulnerable populations selected. Participants are adult women aged 18-40. Written informed consent is required from each participant (inclusion: "Willingness to use trial medication and to sign a written informed consent"); sufficient knowledge of Finnish is required. No assent procedures are indicated.

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":"- PCOS diagnosis according to Rotterdam criteria: clinical or biochemical hyperandrogenism, and/or PCOM, and/or menstrual irregularities."}
  • {"criterion_text":"- Healthy aside from PCOS, no clinically significant illnesses diagnosed by a health care provider, nor any continuous medical treatment"}
  • {"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":"- 6-month use of study preparation, endpoint visit","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
True, recruitment includes social media advertisements and online contact channels (e.g., coco3tutkimus@pohde.fi, coco3tutkimus@hus.fi) for initial contact.
Planned Sample Size
156
Recruitment Window Months
42
Consent Approach
Written informed consent required from each participant. Inclusion criteria require willingness to sign a written informed consent and sufficient knowledge of Finnish to understand study documents. Consent is provided by the participant herself (adult women); no assent procedure indicated.

Methods

  • Print advertisements (document: K2_mainos_painettava_CoCo3) targeting women with PCOS in Finland.
  • Social media advertisements (document: K2_mainos_some_Coco3) targeting women with PCOS in Finland.
  • Recruitment arrangements documented (K1_Recruitment arrangements_CoCo3-PCOS) describing site and local recruitment processes.
  • Site-based recruitment via study sites and research services (Pohde Tutkimuspalvelut, University of Oulu, HUS) with contact emails provided for potential participants.

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
20-04-2026
Processing Time Days
35
Number Of Sites
2
Number Of Participants
156

Sites

Site Name
HUS-yhtymae
Department Name
Obstetrics & Gynecology
Contact Person Name
Kaisu Luiro-Helve
Contact Person Email
coco3tutkimus@hus.fi
Site Name
University Of Oulu
Department Name
Obstetrics & Gynecology
Contact Person Name
Terhi Piltonen
Contact Person Email
coco3tutkimus@pohde.fi

Sponsor

Primary sponsor

Full Name
Pohjois-Pohjanmaan hyvinvointialue
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

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
Route
Oral
Authorisation Status
Authorised
Starting Dose
3 mg drospirenone / 14.2 mg estetrol (film-coated tablet)
Frequency
Maximum daily: 2 tablets
Maximum Dose
2 tablets per day
Investigational Product Name
Daylette 0,02 mg / 3 mg tabletti, kalvopäällysteinen
Active Substance
Drospirenone; Ethinylestradiol
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Starting Dose
0.02 mg ethinylestradiol / 3 mg drospirenone (film-coated tablet)
Frequency
Maximum daily: 2 tablets
Maximum Dose
2 tablets per day
Investigational Product Name
Slinda 4 mg kalvopäällysteinen tabletti
Active Substance
Drospirenone
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised
Starting Dose
4 mg drospirenone (film-coated tablet)
Frequency
Maximum daily: 2 tablets
Maximum Dose
2 tablets per day
Combination Treatment
Yes

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