Trial · NCT07120815
Optimizing Metformin Use in Polycystic Ovary Syndrome
NCT07120815, Phase 3, Not yet recruiting, Helsinki University Central Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimizing Metformin Use in Polycystic Ovary Syndrome. Trials, record NCT07120815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07120815
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimizing Metformin Use in Polycystic Ovary Syndrome
- NCT number
- NCT07120815
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 184 participants, estimated
- Lead sponsor
- Helsinki University Central Hospital
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Interventions
- Metformin 1500 mg daily, Metformin 2250 mg daily
- First posted
- 2025-08-13
- Last updated
- 2025-08-13
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weight | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | Weight will be measured by a standard scale to an accuracy of +/- 0,1kg. |
| Primary | Homeostatic model assessment for insulin resistance (HOMA-IR) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | HOMA-IR will be calculated with the formula: fasting plasma glucose (mmol/L) × fasting serum insulin (mU/L) divided by 22.5 (9) |
| Primary | Hirsutism | The investigators will report change from baseline to 14 and 26 weeks. | Modified Ferriman Gallwey score (mFG) will be measured and a score of 4 or more will be regarded as hirsutism in Caucasian women, whereas a score of 6 or more will be regarded hirsutism for other ethnicities |
| Primary | Total testosterone | The investigators will measure change from baseline to 14 and 26 weeks | Testosterone nmol/l (liquid chromatography with tandem mass spectrometry (LC-MS/MS). All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
| Primary | Appearance of severe of adverse effects | The investigators will measure change from baseline to 14 and 26 weeks | In our questionnaire the investigators will ask the participants whether they have experienced abdominal pain, reflux, nausea, diarrhoea or loss of appetite during the last two weeks and grade the symptoms from 1-5 (1 being never and 5 being all the time). The investigators will count the scores and give each participant a score between 5-25. A severe adverse effect is defined as a score of 4 or more in one of the questions (indicating a daily experience of abdominal pain, reflux, nausea, diarrhoea or loss of appetite during the last two weeks). |
| Primary | Anti-Mullerian hormone (AMH) | The investigators will measure change from baseline to 14 and 26 weeks | AMH will be measured in ug/l. All laboratory tests will be taken in the morning, between 7-10 am, after 12 hours fasting. |
| Secondary | Body mass index (BMI) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | Weight (kilogram) and height (metre) will be combined to report BMI in kg/m\^2 |
| Secondary | Waist circumference (WC) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | WC will be measured halfway between the participant's lowest rib and the top of the participant's hipbone |
| Secondary | Waist-hip-ratio (WHR) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | WHR will be calculated as waist measurement divided by hip measurement (W⁄H). Hip circumference is determined as the maximum value over the glottal region, measured to the nearest centimetre. |
| Secondary | Body adiposity index (BAI) | The investigators will measure change in outcomes from baseline to 14 and 26 weeks | BAI will be measured using the following equation: hip circumference (cm)/height (m) - 18 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41819580 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07120815
GET https://conductscience.org/api/trials/v1/NCT07120815/registered?page=2