A Phase 4 interventional study of Metformin in Polycystic Ovary Syndrome (PCOS) Women and Insulin Resistance Syndrome, sponsored by Jerash Private University. Completed at 1 site in Jordan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Jerash Private University · Phase 4, Interventional, and Treatment
This prospective longitudinal interventional study aims to evaluate the effects of routine metformin therapy on metabolic, iron-related, erythropoietin, lipid, and hematological parameters in adult women with polycystic ovary syndrome (PCOS). Participants diagnosed with PCOS according to established diagnostic criteria receive routine metformin therapy for six months as part of standard clinical care. Clinical and laboratory assessments are performed at baseline, three months, and six months to evaluate changes in insulin resistance, fasting blood glucose, fasting serum insulin, serum ferritin, serum iron, erythropoietin (EPO), lipid profile, and hematological indices. The study also examines the relationships between metabolic, iron-related, and hematological biomarkers during metformin treatment.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders affecting women of reproductive age and is frequently associated with insulin resistance, dyslipidemia, obesity, and an increased risk of metabolic complications. Although metformin is widely prescribed to improve insulin sensitivity in women with PCOS, its effects on iron metabolism, erythropoietin concentrations, and hematological parameters remain incompletely understood.
This prospective longitudinal interventional study was conducted among adult women with PCOS attending obstetrics and gynecology clinics of the Jordanian Ministry of Health. Eligible participants received routine metformin therapy (500 mg twice daily) for six months as part of standard clinical practice. No additional behavioral, lifestyle, dietary, or educational interventions were provided as part of the study protocol.
Clinical and laboratory assessments were performed at baseline, after three months, and after six months of treatment. Outcome measures included body mass index (BMI), fasting blood glucose (FBG), fasting serum insulin, homeostatic model assessment of insulin resistance (HOMA-IR), lipid profile (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol), serum ferritin, serum iron, erythropoietin (EPO), hemoglobin concentration, complete blood count, and red blood cell indices.
The primary objective was to determine the effects of routine metformin therapy on insulin resistance, iron metabolism, erythropoietin concentrations, and hematological parameters in women with PCOS. Secondary objectives included evaluating changes in lipid profile and investigating the associations among metabolic, iron-related, and hematological biomarkers during the six-month follow-up period.
The findings of this study are expected to improve understanding of the metabolic and hematological effects of routine metformin therapy in women with PCOS and to clarify the relationship between insulin resistance, iron homeostasis, erythropoietin, and metabolic outcomes in this population.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 25 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Jerash Private University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult women diagnosed with polycystic ovary syndrome (PCOS) received routine metformin therapy (500 mg orally twice daily) for six months as part of standard clinical care. Clinical and laboratory assessments were performed at baseline, three months, and six months to evaluate changes in insulin resistance, iron metabolism, erythropoietin concentrations, lipid profile, and hematological parameters.
Drug: Metformin
Metformin hydrochloride tablets, 500 mg administered orally twice daily for six months as part of routine clinical management of women with polycystic ovary syndrome (PCOS).
Change in insulin resistance (HOMA-IR)
To evaluate the change in insulin resistance using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) following six months of routine metformin therapy in women with polycystic ovary syndrome.
Time frame: Baseline and 6 months
Change in serum ferritin concentration
To evaluate the change in serum ferritin concentration after six months of routine metformin therapy.
Time frame: Baseline and 6 months
Change in fasting blood glucose
Time frame: Baseline and 6 months
Change in fasting serum insulin
Time frame: Baseline and 6 months
Change in serum iron concentration
Time frame: Baseline and 6 months
Change in hematological parameters
Changes in hemoglobin concentration, red blood cell indices, and complete blood count parameters.
Time frame: Baseline and 6 months
Change in body mass index (BMI)
Time frame: Baseline and 6 months
Plan to share: Yes — Individual participant data (IPD) underlying the results reported in this study, after de-identification, will be made available upon reasonable request to the corresponding author. Data will be shared for scientifically sound research purposes after approval of a methodologically appropriate proposal and execution of a data access agreement. Supporting documents, including the study protocol and statistical analysis plan, may also be made available upon request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication.
Access criteria: De-identified individual participant data, the study protocol, and the statistical analysis plan will be available to qualified researchers upon reasonable request. Requests must include a scientifically sound research proposal. Access will be granted following review and approval by the corresponding author and the sponsoring institution, and after execution of a data sharing agreement to ensure participant confidentiality and appropriate use of the data.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin
Jerash Private University