Clinical trial · Interventional
Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)
Targeting Pathophysiologic Pathways in Polycystic Ovary Syndrome Using a Response to Metformin Phenotype
- 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 investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can be separated into subtypes based on their response to metformin. The investigators propose here to use both targeted and non-targeted metabolomic approach to identify pathways associated with metformin's effect on insulin sensitivity and endothelial function. This pilot project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets.
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 (2)
- type
- EXPERIMENTAL
- label
- Metformin
- description
- Metformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.
- interventionNames
- Drug: Metformin
- type
- OTHER
- label
- Delayed Start Metformin
- description
- After baseline study visit, this arm will return after three months without metformin for a repeat of the baseline study visit prior to initiating metformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.
- interventionNames
- Drug: Metformin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Body mass index (BMI) greater than or equal to 25 * Polycystic Ovary Syndrome criteria of both oligomenorrhea (\<9 menses per year) and androgen excess \[clinical hirsutism (Ferriman-Gallway score \>8 or severe acne) or elevated testosterone\]. * Taking no medications for the treatment of insulin resistance. Exclusion Criteria: * Diagnosis of Cushing's syndrome * Untreated hypo/hyperthyroidism * Elevated prolactin * Congenital adrenal hyperplasia * Renal insufficiency (creatinine \> 1.5) * Diabetes * Medications that can significantly affect endothelial function * Pregnancy * Breast Feeding * Taking oral contraceptives * Currently smoking
References
Publications (1)
- DERIVEDHeidari B, Lerman A, Lalia AZ, Lerman LO, Chang AY. Effect of Metformin on Microvascular Endothelial Function in Polycystic Ovary Syndrome. Mayo Clin Proc. 2019 Dec;94(12):2455-2466. doi: 10.1016/j.mayocp.2019.06.015. PMID 31806099