Polycystic Ovary Syndrome (PCOS) WomenPhase 4MET-PCOSNCT07793838
Metformin Effects on Metabolic, Vitamin B12, Iron, Erythropoietin, and Hematological Parameters in Women With PCOS
A Phase 4 study testing Metformin in people with Polycystic Ovary Syndrome (PCOS) Women, run by Jerash Private University at 1 site in Jordan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS) Women
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteJordan
- Study dates
- 1 Aug 2025to 1 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
obstetrics and gynecology clinics affiliated with the Ministry of Health in Jordan،
Amman, 009627
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Polycystic Ovary Syndrome (PCOS) Women
- Being tested
- Metformin, Matching Placebo
- Keywords
- Metformin, Insulin Resistance, Polycystic Ovary Syndrome, HOMA-IR, Vitamin B12, Iron Status, Ferritin, Erythropoietin, Hematological Parameters
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin was administered at a total daily dose of 1500 mg in three divided doses with meals for six months.
Matching PlaceboDrug
A matching placebo was administered according to the same schedule as the metformin intervention for six months.
| Study group | Role | What they receive |
|---|---|---|
| Metformin Intervention Group | Experimental | 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. Receives: Drug: Metformin |
| Matching Placebo Group | Placebo comparator | 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. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal change in serum iron
Change in serum iron from baseline through 3 months and 6 months during the study intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Aug 2025
- Primary completion1 Feb 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary Syndrome (PCOS) WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly allocated in a 1:1 ratio to two parallel groups: a metformin intervention group and a matching placebo group. The assigned intervention was continued for six months, with assessments conducted at baseline, 3 months, and 6 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerash Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAWAD AHMAD ABU-SHENNAR, Jerash Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793838
- Sponsor's protocol ID
- Metformin-Placebo-2026
- Acronym
- MET-PCOS
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Escobar-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.
PubMed 22579050Greibe 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.
PubMed 23857221
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07793838
- Acronym / sponsor ID
- MET-PCOS / Metformin-Placebo-2026
- Conditions
- Polycystic Ovary Syndrome (PCOS) Women
- Keywords
- Metformin, Insulin Resistance, Polycystic Ovary Syndrome, HOMA-IR, Vitamin B12, Iron Status, Ferritin, Erythropoietin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Jerash Private UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly allocated in a 1:1 ratio to two parallel groups: a metformin intervention group and a matching placebo group. The assigned intervention was continued for six months, with assessments conducted at baseline, 3 months, and 6 months.
| Arm | Type | Receives |
|---|---|---|
| Metformin Intervention Group | Experimental | Drug: MetforminParticipants 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. |
| Matching Placebo Group | Placebo comparator | Drug: Matching PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Chronic hemolytic anemia.
- Chronic kidney disease.
- Endocrine disorders other than PCOS.
- Hepatic disorders.
- Metabolic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin was administered at a total daily dose of 1500 mg in three divided doses with meals for six months. | Drug | Metformin Intervention Group |
| Matching PlaceboA matching placebo was administered according to the same schedule as the metformin intervention for six months. | Drug | Matching Placebo Group |
Primary outcome
Longitudinal change in serum iron
Time frame: Baseline, 3 months, and 6 months
Change in serum iron from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in total iron-binding capacity
Time frame: Baseline, 3 months, and 6 months
Change in total iron-binding capacity (TIBC) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in serum ferritin
Time frame: Baseline, 3 months, and 6 months
Change in serum ferritin from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in transferrin saturation
Time frame: Baseline, 3 months, and 6 months
Change in transferrin saturation (TSAT) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in serum vitamin B12
Time frame: Baseline, 3 months, and 6 months.
Change in serum vitamin B12 level from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in erythropoietin
Time frame: Baseline, 3 months, and 6 months.
Change in serum erythropoietin (EPO) level from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in hemoglobin
Time frame: Baseline, 3 months, and 6 months.
Change in hemoglobin (Hb) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in hematocrit
Time frame: Baseline, 3 months, and 6 months.
Change in hematocrit (Hct) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in red blood cell count
Time frame: Baseline, 3 months, and 6 months.
Change in red blood cell (RBC) count from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in mean corpuscular volume
Time frame: Baseline, 3 months, and 6 months.
Change in mean corpuscular volume (MCV) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in mean corpuscular hemoglobin
Time frame: Baseline, 3 months, and 6 months.
Change in mean corpuscular hemoglobin (MCH) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in mean corpuscular hemoglobin concentration
Time frame: Baseline, 3 months, and 6 months.
Change in mean corpuscular hemoglobin concentration (MCHC) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in red cell distribution width
Time frame: Baseline, 3 months, and 6 months.
Change in red cell distribution width (RDW-CV) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in white blood cell count
Time frame: Baseline, 3 months, and 6 months.
Change in white blood cell (WBC) count from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in lymphocyte count
Time frame: Baseline, 3 months, and 6 months.
Change in lymphocyte count from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in neutrophil count
Time frame: Baseline, 3 months, and 6 months.
Change in neutrophil count from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in eosinophil count
Time frame: Baseline, 3 months, and 6 months.
Change in eosinophil count from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in basophil count
Time frame: Baseline, 3 months, and 6 months.
Change in basophil count from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in monocyte count
Time frame: Baseline, 3 months, and 6 months.
Change in monocyte count from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in platelet count
Time frame: Baseline, 3 months, and 6 months.
Change in platelet (PLT) count from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in HOMA-IR
Time frame: Baseline, 3 months, and 6 months
Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in fasting blood glucose
Time frame: Baseline, 3 months, and 6 months
Change in fasting blood glucose (FBG) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in total cholesterol
Time frame: Baseline, 3 months, and 6 months
Change in total cholesterol (TC) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in triglycerides
Time frame: Baseline, 3 months, and 6 months
Change in triglycerides (TG) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in low-density lipoprotein cholesterol
Time frame: Baseline, 3 months, and 6 months.
Change in low-density lipoprotein cholesterol (LDL-C) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in high-density lipoprotein cholesterol
Time frame: Baseline, 3 months, and 6 months.
Change in high-density lipoprotein cholesterol (HDL-C) from baseline through 3 months and 6 months during the study intervention.
Longitudinal change in body mass index
Time frame: Baseline, 3 months, and 6 months.
Change in body mass index (BMI) from baseline through 3 months and 6 months during the study intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 22579050Escobar-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.
- Results publication: PubMed 23857221Greibe 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.
- Individual participant dataSharing planned: 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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PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Polycystic Ovary Syndrome (PCOS) Women, run by Jerash Private University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal change in serum iron (time frame: Baseline, 3 months, and 6 months). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07793838, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.