A Phase 4 interventional study of Metformin and Matching Placebo in Polycystic Ovary Syndrome (PCOS) Women, sponsored by Jerash Private University. Completed at 1 site in Jordan. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Jerash Private University · Phase 4, Interventional, and Treatment
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.
Polycystic ovary syndrome (PCOS) is a common and heterogeneous endocrine and metabolic disorder characterized by reproductive, endocrine, and metabolic abnormalities. Insulin resistance, hyperinsulinemia, dyslipidemia, excess weight, and disturbances in reproductive function are important components of the PCOS phenotype. Metformin is an insulin-sensitizing medication widely used to address metabolic abnormalities associated with PCOS.
This double-blind, placebo-controlled, parallel-group randomized controlled trial was designed to evaluate longitudinal changes in metabolic, vitamin B12, iron-status, erythropoietic, and hematological parameters among women with PCOS during six months of metformin therapy. The study also examined selected associations among demographic, clinical, reproductive, familial, metabolic, vitamin B12, iron-status, erythropoietic, and hematological characteristics.
Women aged 18-40 years with PCOS confirmed by a specialist in Obstetrics and Gynecology were eligible for participation. Participants were excluded if they had chronic hemolytic anemia, chronic kidney disease, endocrine disorders other than PCOS, hepatic disorders, metabolic disorders, cardiovascular disease, or other concurrent medical conditions that could influence glucose metabolism, iron status, vitamin B12, erythropoietin, or hematological parameters. Women who had received insulin-sensitizing agents, iron supplementation, hormonal therapy, vitamin B12 supplementation, or other medications known to substantially affect the study outcomes during the predefined period before enrollment were also excluded.
Following baseline assessment, eligible participants were randomly allocated in a 1:1 ratio using a computer-generated random allocation sequence to either the metformin intervention group or the matching placebo group. Participants in the intervention group received metformin at a total daily dose of 1500 mg, administered in three divided doses with meals. Participants in the control group received a corresponding matching placebo according to the same administration schedule. Both groups continued to receive routine clinical care.
The double-blind design was maintained throughout the study. Participants were blinded to treatment allocation, and investigators involved in participant assessment and outcome evaluation were also blinded to treatment assignment. Matching preparations were used to minimize the possibility of identifying treatment allocation based on appearance.
Clinical, anthropometric, biochemical, iron-status, vitamin B12, erythropoietic, and hematological assessments were performed at three predefined time points: baseline, 3 months, and 6 months. Metabolic assessments included body mass index, fasting blood glucose, serum insulin, HOMA-IR, total cholesterol, triglycerides, LDL-C, and HDL-C. Iron-status assessments included serum iron, total iron-binding capacity, ferritin, and transferrin saturation. Serum vitamin B12 and erythropoietin were also assessed. Hematological assessments included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, white blood cell count, lymphocytes, neutrophils, eosinophils, basophils, monocytes, and platelet count.
The study was conducted in obstetrics and gynecology clinics affiliated with the Ministry of Health in Jordan. The study period extended from August 2025 to February 2026. A total of 400 women were initially enrolled and randomly allocated, with 200 participants assigned to each treatment group. During the six-month follow-up period, 100 participants did not complete the required assessments, leaving 300 participants in the final longitudinal analysis, comprising 150 participants in the metformin group and 150 participants in the matching placebo group.
No additional structured educational, behavioral, lifestyle, or self-management intervention was introduced as part of the study protocol. Participants continued to receive routine clinical care. Lifestyle behaviors, including physical activity, dietary intake, and adherence to lifestyle recommendations, were not systematically quantified using validated assessment instruments.
Longitudinal changes across baseline, 3 months, and 6 months were evaluated using repeated-measures analysis of variance. Associations between selected continuous variables were examined using Pearson's correlation coefficient when appropriate, while Spearman's rank-order correlation coefficient was used for ordinal variables or variables that did not meet the assumptions required for Pearson correlation. Correlation analyses were considered exploratory and hypothesis-generating because multiple associations were examined.
The study received ethical approval from the Ethical Board of the Jordanian Ministry of Health, Amman, Jordan (Approval No. 99923), and the Institutional Review Board of Al-Ahliyya Amman University (Approval No. 2026-2025/30/1). Written informed consent was obtained from all participants before enrollment. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 400 is above 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.
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.
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.
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.
Drug: Metformin
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.
Drug: Matching Placebo
Metformin was administered at a total daily dose of 1500 mg in three divided doses with meals for six months.
A matching placebo was administered according to the same schedule as the metformin intervention for six months.
Longitudinal change in serum iron
Change in serum iron from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months
Longitudinal change in total iron-binding capacity
Change in total iron-binding capacity (TIBC) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months
Longitudinal change in serum ferritin
Change in serum ferritin from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months
Longitudinal change in transferrin saturation
Change in transferrin saturation (TSAT) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months
Longitudinal change in serum vitamin B12
Change in serum vitamin B12 level from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in erythropoietin
Change in serum erythropoietin (EPO) level from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in hemoglobin
Change in hemoglobin (Hb) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in hematocrit
Change in hematocrit (Hct) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in red blood cell count
Change in red blood cell (RBC) count from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in mean corpuscular volume
Change in mean corpuscular volume (MCV) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in mean corpuscular hemoglobin
Change in mean corpuscular hemoglobin (MCH) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in mean corpuscular hemoglobin concentration
Change in mean corpuscular hemoglobin concentration (MCHC) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in red cell distribution width
Change in red cell distribution width (RDW-CV) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in white blood cell count
Change in white blood cell (WBC) count from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in lymphocyte count
Change in lymphocyte count from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in neutrophil count
Change in neutrophil count from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in eosinophil count
Change in eosinophil count from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in basophil count
Change in basophil count from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in monocyte count
Change in monocyte count from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in platelet count
Change in platelet (PLT) count from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in HOMA-IR
Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months
Longitudinal change in fasting blood glucose
Change in fasting blood glucose (FBG) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months
Longitudinal change in total cholesterol
Change in total cholesterol (TC) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months
Longitudinal change in triglycerides
Change in triglycerides (TG) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months
Longitudinal change in low-density lipoprotein cholesterol
Change in low-density lipoprotein cholesterol (LDL-C) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in high-density lipoprotein cholesterol
Change in high-density lipoprotein cholesterol (HDL-C) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Longitudinal change in body mass index
Change in body mass index (BMI) from baseline through 3 months and 6 months during the study intervention.
Time frame: Baseline, 3 months, and 6 months.
Plan to share: No — Individual participant data will not be shared with other researchers because no plan for sharing individual participant-level data was established as part of the study.
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Studies of the drug tested here: Metformin
Jerash Private University