Clinical trial · Interventional
Metformin Effects on Metabolic, Vitamin B12, Iron, Erythropoietin, and Hematological Parameters in Women With PCOS
The Effects of Metformin Therapy on Changes in Metabolic, Vitamin B12, Iron Status, Erythropoietin, and Hematological Parameters Among Women With Polycystic Ovary Syndrome: A Double-Blind Randomized Controlled Trial
- 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)
This double-blind, placebo-controlled, parallel-group randomized controlled trial evaluated changes in metabolic, vitamin B12, iron-status, erythropoietic, and hematological parameters among women with polycystic ovary syndrome (PCOS) receiving metformin therapy. Women aged 18-40 years with a diagnosis of PCOS confirmed by a specialist in Obstetrics and Gynecology were randomly assigned in a 1:1 ratio to either a metformin intervention group or a matching placebo group. Participants in the metformin group received a total daily dose of 1500 mg metformin, administered in three divided doses with meals, while participants in the control group received a matching placebo. Both groups continued to receive routine clinical care. Clinical and laboratory assessments were performed at baseline, 3 months, and 6 months. The study evaluated metabolic measures, including fasting blood glucose, serum insulin, HOMA-IR, total cholesterol, triglycerides, LDL-C, HDL-C, and body mass index. Iron-status measures included serum iron, total iron-binding capacity, ferritin, and transferrin saturation. Serum vitamin B12 and erythropoietin were also assessed, together with hematological parameters including hemoglobin, hematocrit, red blood cell indices, white blood cell counts and differential counts, and platelet count. The study enrolled 400 participants, with 200 participants initially allocated to each treatment group. After loss to follow-up, 300 participants completed the required assessments and were included in the final longitudinal analysis, with 150 participants in each group. The study was designed to characterize longitudinal changes in metabolic, nutritional, iron-related, erythropoietic, and hematological parameters during six months of metformin therapy in women 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 |
|---|---|---|---|
| Polycystic Ovary Syndrome (PCOS) Women | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Matching Placebo | Drug | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin Intervention Group
- description
- Participants assigned to the metformin intervention group received metformin at a total daily dose of 1500 mg, administered in three divided doses with meals, for six months in addition to routine clinical care. Clinical and laboratory assessments were performed at baseline, 3 months, and 6 months.
- interventionNames
- Drug: Metformin
- type
- PLACEBO_COMPARATOR
- label
- Matching Placebo Group
- description
- Participants assigned to the matching placebo group received a corresponding matching placebo according to the same administration schedule for six months in addition to routine clinical care. Clinical and laboratory assessments were performed at baseline, 3 months, and 6 months.
- interventionNames
- Drug: Matching Placebo
Primary outcomes (27)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18-40 years. * Diagnosis of polycystic ovary syndrome (PCOS) confirmed by a specialist in Obstetrics and Gynecology. * Eligible participants who met the study requirements and provided written informed consent. Exclusion Criteria: * Chronic hemolytic anemia. * Chronic kidney disease. * Endocrine disorders other than PCOS. * Hepatic disorders. * Metabolic disorders. * Cardiovascular disease. * Other concurrent medical conditions that could influence glucose metabolism, iron status, vitamin B12, erythropoietin, or hematological parameters. * Previous use of insulin-sensitizing agents, iron supplementation, hormonal therapy, vitamin B12 supplementation, or other medications known to substantially affect glucose metabolism, iron metabolism, erythropoietin levels, or hematological parameters during the predefined period before enrollment.
References
Publications (2)
- RESULTEscobar-Morreale HF. Iron metabolism and the polycystic ovary syndrome. Trends Endocrinol Metab. 2012 Oct;23(10):509-15. doi: 10.1016/j.tem.2012.04.003. Epub 2012 May 10. PMID 22579050
- RESULTGreibe E, Trolle B, Bor MV, Lauszus FF, Nexo E. Metformin lowers serum cobalamin without changing other markers of cobalamin status: a study on women with polycystic ovary syndrome. Nutrients. 2013 Jul 5;5(7):2475-82. doi: 10.3390/nu5072475. PMID 23857221