Clinical trial · Interventional
Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
- 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)
Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2 Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation. In every day medical practice lower doses of Metformin are administered searching for the continuation of the treatment. However, there is no clinical study to support this assertion. The objective of this study is to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking daily doses of 1500mg and 1000mg.
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 |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Metformin
- description
- study parallel with one arm only.
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Plasma concentration of metformin
- timeFrame
- First day after administration until 3 months after begining of treatment
- description
- Blood samples are collected from each patient and the plasma concentration is analysed.
Secondary outcomes (1)
- measure
- Number of adverse events
- timeFrame
- observation during 3 months of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged between 18 and 40 years old, with no use of contraceptive drugs or insulin sensitizing agents for more than 3 months. * PCOS diagnosis. * Insulin resistance Index by the Homeostatic model Assessment Formula higher than 2.5. Exclusion Criteria: * Another diseases with androgen excess; * Patients with history of serious adverse reaction or hypersensibility to any medicine; * History or presence of renal, hepatic or gastrointestinal disorders. * Continuous use of any pharmaco, inclusively metformin
References
Publications (0)
Data not yet available