Clinical trial · Interventional
Effect of Metformin on Patients With Polycystic Ovary Syndrome
Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome
NCT05802212CI-TRIAL-00097909completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to understand the effect of Metformin on patients with PCOS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin intervention for 12 weeks | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin intervention for 12 weeks
- description
- Metformin intervention for 12 weeks
- interventionNames
- Drug: Metformin intervention for 12 weeks
Primary outcomes (2)
- measure
- Luteinizing hormone in serum
- timeFrame
- before and after 2, 12 weeks of intervention
- description
- Changes of luteinizing hormone(mIU/mL) in serum after the intervention.
- measure
- 4-Androstenedione in serum
- timeFrame
- before and after 2, 12 weeks of intervention
- description
- Changes of 4-Androstenedione(pmol/L) in serum after the intervention.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Individuals who are 20 to 40 years old, planning to become pregnant or infertile women. 2. Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome). 3. Individuals who can insist on continuous monitoring in the outpatient clinic. Individuals who are not participating in other research projects currently or 3 months before the intervention. 4. Volunteers with polycystic ovary syndrome without insulin resistance. Exclusion Criteria: 1. Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities. 2. Individuals who are during pregnant, lactation or menopause. 3. Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. 4. Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months. 5. Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. 6. Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months. 7. Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. 8. A medical history of severe cardiovascular and cerebrovascular diseases. 9. Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. 10. Individuals who drink more than 15g of alcohol per day or have a smoking habit. 11. Individuals who need drug treatment for any mental illness such as epilepsy and depression. 12. Cancer patients. 13. Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
References
Publications (0)
Data not yet available
No reference posted for this study.