Polycystic Ovary Syndrome (PCOS) WomenPhase 4Metformin-APONCT07759674
Relationship Between Metformin Treatment, Anemia, and Erythropoietin Levels in Women With Polycystic Ovary Syndrome in Jordan
A Phase 4 study testing Metformin in people with Polycystic Ovary Syndrome (PCOS) Women and Insulin Resistance Syndrome, run by Jerash Private University at 1 site in Jordan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS) Women, Insulin Resistance Syndrome
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jun 2023to 1 Dec 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-45 years.
- Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam diagnostic criteria.
- Eligible for routine metformin therapy as determined by the treating gynecologist.
- Willing and able to provide written informed consent.
- Willing to attend scheduled follow-up visits and complete all study assessments over the six-month study period.
Who cannot join
- Pregnancy or breastfeeding.
- Diagnosis of type 1 diabetes mellitus or established type 2 diabetes requiring insulin therapy.
- History of chronic kidney disease, chronic liver disease, hematological disorders, malignancy, or other severe systemic diseases.
- Current use of medications known to affect glucose metabolism, iron metabolism, erythropoietin levels, or hematological parameters within the previous three months, other than routine metformin prescribed as part of the study.
- Known hypersensitivity or contraindication to metformin. Inability or unwillingness to complete the scheduled follow-up assessments.
- Participation in another interventional clinical trial during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Routine Metformin Therapy on Insulin Resistance, Iron Metabolism, Erythropoietin, Lipid Profile, and Hematological Parameters in Jordanian Women With Polycystic Ovary Syndrome: A Prospective Longitudinal Interventional Study
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.
Read the detailed description
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.
- Being tested
- Metformin
- Keywords
- Polycystic Ovary Syndrome, Metformin, Insulin Resistance
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Routine Metformin Therapy | Experimental | 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. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Change in serum ferritin concentration
To evaluate the change in serum ferritin concentration after six months of routine metformin therapy.
Measured: Baseline and 6 months
Secondary outcomes (5)
Change in fasting blood glucose
Measured: Baseline and 6 months
Change in fasting serum insulin
Measured: Baseline and 6 months
Change in serum iron concentration
Measured: Baseline and 6 months
Change in hematological parameters
Changes in hemoglobin concentration, red blood cell indices, and complete blood count parameters.
Measured: Baseline and 6 months
Change in body mass index (BMI)
Measured: Baseline 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 posted12 Aug 2026
- Study start1 Jun 2023
- Primary completion1 Sep 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Not applicable
- Intervention model
- Single group
- Model description
- This was a prospective single-group longitudinal interventional study. All enrolled participants with polycystic ovary syndrome (PCOS) received routine metformin therapy (500 mg twice daily) for six months. Clinical and laboratory assessments were performed at baseline, three months, and six months to evaluate changes in metabolic, iron-related, lipid, erythropoietin, and hematological parameters. No parallel control group was included.
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT07759674
- Sponsor's protocol ID
- Metformin --2026
- Acronym
- Metformin-APO
- Status last verified
- Jun 2023
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.
PubMed 14711538Johnson NP. Metformin use in women with polycystic ovary syndrome. Ann Transl Med. 2014 Jun;2(6):56. doi: 10.3978/j.issn.2305-5839.2014.04.15.
PubMed 25333031Teede HJ, Tay CT, Laven J, Dokras A, Moran LJ, Piltonen TT, Costello MF, Boivin J, M Redman L, A Boyle J, Norman RJ, Mousa A, Joham AE; International PCOS Network. Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. Fertil Steril. 2023 Oct;120(4):767-793. doi: 10.1016/j.fertnstert.2023.07.025. Epub 2023 Aug 14.
PubMed 37589624
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Routine Metformin Therapy on Insulin Resistance, Iron Metabolism, Erythropoietin, Lipid Profile, and Hematological Parameters in Jordanian Women With Polycystic Ovary Syndrome: A Prospective Longitudinal Interventional Study
- ClinicalTrials.gov ID
- NCT07759674
- Acronym / sponsor ID
- Metformin-APO / Metformin --2026
- Keywords
- Polycystic Ovary Syndrome, Metformin, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jerash Private UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 12 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This was a prospective single-group longitudinal interventional study. All enrolled participants with polycystic ovary syndrome (PCOS) received routine metformin therapy (500 mg twice daily) for six months. Clinical and laboratory assessments were performed at baseline, three months, and six months to evaluate changes in metabolic, iron-related, lipid, erythropoietin, and hematological parameters. No parallel control group was included.
| Arm | Type | Receives |
|---|---|---|
| Routine Metformin Therapy | Experimental | Drug: MetforminAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18-45 years.
- Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam diagnostic criteria.
- Eligible for routine metformin therapy as determined by the treating gynecologist.
- Willing and able to provide written informed consent.
- Willing to attend scheduled follow-up visits and complete all study assessments over the six-month study period.
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding.
- Diagnosis of type 1 diabetes mellitus or established type 2 diabetes requiring insulin therapy.
- History of chronic kidney disease, chronic liver disease, hematological disorders, malignancy, or other severe systemic diseases.
- Current use of medications known to affect glucose metabolism, iron metabolism, erythropoietin levels, or hematological parameters within the previous three months, other than routine metformin prescribed as part of the study.
- Known hypersensitivity or contraindication to metformin. Inability or unwillingness to complete the scheduled follow-up assessments.
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 hydrochloride tablets, 500 mg administered orally twice daily for six months as part of routine clinical management of women with polycystic ovary syndrome (PCOS). | Drug | Routine Metformin Therapy |
Primary outcome
Change in insulin resistance (HOMA-IR)
Time frame: Baseline and 6 months
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.
Change in serum ferritin concentration
Time frame: Baseline and 6 months
To evaluate the change in serum ferritin concentration after six months of routine metformin therapy.
5 secondary outcomes
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
Time frame: Baseline and 6 months
Change in body mass index (BMI)
Time frame: Baseline and 6 months
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 12 Aug 2026.
- Background: PubMed 14711538Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.
- Results publication: PubMed 25333031Johnson NP. Metformin use in women with polycystic ovary syndrome. Ann Transl Med. 2014 Jun;2(6):56. doi: 10.3978/j.issn.2305-5839.2014.04.15.
- Results publication: PubMed 37589624Teede HJ, Tay CT, Laven J, Dokras A, Moran LJ, Piltonen TT, Costello MF, Boivin J, M Redman L, A Boyle J, Norman RJ, Mousa A, Joham AE; International PCOS Network. Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. Fertil Steril. 2023 Oct;120(4):767-793. doi: 10.1016/j.fertnstert.2023.07.025. Epub 2023 Aug 14.
- Individual participant dataSharing planned: 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.
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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 and Insulin Resistance Syndrome, 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 5 inclusion and 6 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 12 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. 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?
Change in insulin resistance (HOMA-IR) (time frame: Baseline and 6 months). The study lists 2 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 NCT07759674, which also lists 3 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 12 Aug 2026.