Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
184
Countries
1
Sites
1
Polycystic ovary syndrome
To find out if a metformin dose of 1500mg is inferior to 2250 mg per day regarding biochemical and clinical outcomes in overweight individuals 18-37 years of age with PCOS.
Key facts
- Sponsor
- HUS-yhtymae
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19], Phenomena and Processes [G] - Metabolism [G03]
- Decision date (initial)
- 2025-02-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Finska Läkaresällskapet · Valtion tutkimusraha (VTR)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Dose response
To find out if a metformin dose of 1500mg is inferior to 2250 mg per day regarding biochemical and clinical outcomes in overweight individuals 18-37 years of age with PCOS.
Secondary objectives 1
- To find out if a metformin dose of 1500mg is inferior to a dose of 2250 mg per day regarding gastrointestinal side effects and psychological well being in overweight individuals 18-37 years of age with PCOS.
Conditions and MedDRA coding
Polycystic ovary syndrome
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509259-15-00 | Optimizing metformin use in polycystic ovary syndrome - A randomized controlled trial | HUS-yhtymae |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Women aged 18-37 years of age
- A diagnosis of PCOS according to the updated 2023 International PCOS guideline
- BMI ≥ 25 kg/m2 and <40 kg/m2
- Signed informed consent and willingness to comply with the trial procedures
Exclusion criteria 10
- Females not meeting the 2003 Rotterdam criteria for PCOS
- Females with hormonal contraceptive during the last 3 months
- Women that are pregnant or breastfeeding
- Females with an untreated diabetes, hypothyroidism or hyperprolactinemia
- Use of medications for diabetes, high cholesterol, obesity and cortisone (per oral)
- Serious mental illness
- Females with contraindication for use of metformin (hypersensitivity to metformin, acute metabolic acidosis, severe renal failure, hepatic insufficiency, heart- or respiratory failure)
- Alcoholism
- A planned surgical intervention during the next 26 weeks
- Investigator site staff directly involved in the conduct of the study and their family members
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- Anthropometrics (weight)
- Androgenicity (hirsutism and testosterone)
- Metabolic (HOMA-IR)
- Gastrointestinal side-effects (nausea, vomiting, abdominal pain)
- Polycystic ovary morphology: AMH
Secondary endpoints 6
- Androgenicity: FAI, SHBG, DHEAS, androstenedione, free testosterone, acne and alopecia
- Menstrual cyclicity (questionnaire where asking how long the two previous cycles were (days)
- Quality of life and weight stigma: anxiety, weight stigma
- Metabolic: fasting glucose, fasting insulin, HbA1C, lipids, CRP, ALAT, GGT, OGTT, FLI, Matsuda Index, TyG index
- Polycystic ovary morphology: ultrasound (follicle number per ovary, ovarian volume)
- Anthropometric (BMI, waist-hip-ratio, WC, BAI, body composition, bloodpressure, pulse)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB08831MIG · Substance
- Active substance
- Metformin
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2500 mg milligram(s)
- Max total dose
- 2500 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03200MIG · Substance
- Active substance
- Metformin Hydrochloride
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2500 mg milligram(s)
- Max total dose
- 2500 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-yhtymae
- Sponsor organisation
- HUS-yhtymae
- Address
- Haartmaninkatu 2, P. O. Box 140 P. O. Box 140
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-yhtymae
- Contact name
- Johanna Melin
Public contact point
- Organisation
- HUS-yhtymae
- Contact name
- Johanna Melin
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 184 | 1 |
| 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 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Clinical Trial Protocol_vers5_clean_version | 1 |
| Protocol (for publication) | Clinical Trial Protocol_vers5_TC | 1 |
| Recruitment arrangements (for publication) | Esitietolomake0_suo_vers2 | 1 |
| Recruitment arrangements (for publication) | Esitietolomake3_6_suo_vers3 | 1 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_en | 1 |
| Recruitment arrangements (for publication) | PCOS-Q_suom_vers2 | 1 |
| Recruitment arrangements (for publication) | PCOS-Q_svenska | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | Rekrytointi_vers2_clean | 1 |
| Recruitment arrangements (for publication) | Rekrytointi_vers2_TC | 1 |
| Recruitment arrangements (for publication) | Response-to_reviewer | 1 |
| Subject information and informed consent form (for publication) | Infokirje ja suostumuskirje-vers5 | 5 |
| Subject information and informed consent form (for publication) | Infokirje ja suostumuskirje-vers5_TC | 5 |
| Subject information and informed consent form (for publication) | Suostumuskirje_ruotsiksi_vers4 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | Summary of product characteristics_vers2 | 1 |
| Synopsis of the protocol (for publication) | Tutkimussuunnitelman_tiivistelma_vers4 | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-23 | Finland | Acceptable 2025-02-05
|
2025-02-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-09 | Finland | Acceptable 2025-02-05
|
2025-02-09 |