Polycystic Ovary Syndrome (PCOS) WomenPhase 4NCT07811856
Effects of Metformin and Theory-Based Education in Women With Polycystic Ovary Syndrome
A Phase 4 study testing MetFORMIN and Theory-Based Behavioral Educational Program in people with Polycystic Ovary Syndrome (PCOS) Women, run by Jerash Private University at 1 site in Jordan.
Trial summary
Polycystic ovary syndrome (PCOS) is a common condition associated with metabolic abnormalities, including insulin resistance, impaired glucose regulation, and abnormal lipid levels. 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 and Theory-Based Behavioral Educational Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteJordan
- Study dates
- 1 Aug 2026to 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.
- Specialist-confirmed diagnosis of polycystic ovary syndrome (PCOS).
- Ability and willingness to participate in the six-month study follow-up.
- Ability to comply with the study procedures and assessments.
Who cannot join
- Chronic hemolytic anemia.
- Chronic kidney disease.
- Hepatic disorders.
- Other endocrine, metabolic, or cardiovascular conditions that could affect glucose metabolism, vitamin B12 status, iron status, erythropoietin levels, or hematological parameters.
- Previous use of insulin-sensitizing medications other than the study metformin.
- Current or recent hormonal therapy that could affect the study outcomes.
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- Current use of iron or vitamin B12 supplements.
- Use of medications that could substantially affect glucose metabolism, vitamin B12 status, iron status, erythropoietin levels, or hematological parameters.
- Any condition that could interfere with adherence to the intervention or completion of the six-month follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Metformin Combined With a Theory-Based Educational Program on Metabolic, Vitamin B12, Iron Status, Erythropoietin, and Hematological Parameters Among Women With Polycystic Ovary Syndrome: A Three-Group Randomized Controlled Trial
Polycystic ovary syndrome (PCOS) is a common condition associated with metabolic abnormalities, including insulin resistance, impaired glucose regulation, and abnormal lipid levels. Metformin is commonly used to improve metabolic outcomes in women with PCOS, while lifestyle modification and behavioral education are important components of PCOS management. This study evaluates whether metformin, alone or combined with a theory-based behavioral educational program, is associated with changes in metabolic, vitamin B12, iron-status, erythropoietin, and hematological parameters compared with matching placebo.
This is a prospective, three-arm, parallel-group randomized controlled trial conducted among women aged 18-40 years with specialist-confirmed PCOS in Ministry of Health obstetrics and gynecology clinics in Jordan. A total of 900 participants were initially randomized in a 1:1:1 ratio to receive matching placebo, metformin, or metformin combined with a theory-based behavioral educational program. The metformin groups received 1500 mg/day, administered as 500 mg three times daily, for six months. The combined intervention group additionally received five structured educational sessions addressing PCOS self-management, healthy dietary practices, physical activity, weight and waist management, metformin adherence, sleep, stress management, problem solving, and maintenance of healthy behaviors.
Clinical and laboratory outcomes were assessed at baseline and after six months. The primary outcomes include changes in anthropometric, metabolic, vitamin B12, iron-status, erythropoietic, and hematological parameters. Changes in PCOS-related knowledge and lifestyle practices were also evaluated among participants receiving the combined intervention.
Read the detailed description
This study is a prospective, three-arm, parallel-group randomized controlled trial conducted among women diagnosed with polycystic ovary syndrome (PCOS). The study was conducted from August 2025 to February 2026 in obstetrics and gynecology clinics affiliated with the Ministry of Health, Jordan. The intervention and follow-up period lasted six months.
A total of 900 eligible participants were initially randomized in a 1:1:1 ratio to one of three study groups: a matching placebo group, a metformin group, and a combined metformin plus theory-based behavioral educational intervention group. All participants received routine clinical care for PCOS.
Participants assigned to the matching placebo group received routine clinical care together with matching placebo tablets identical to the metformin tablets in appearance, size, and form. Participants in the metformin group received routine clinical care together with metformin at a total daily dose of 1500 mg, administered as 500 mg three times daily, for six months. Participants in the combined intervention group received the same metformin regimen together with a structured theory-based behavioral educational program.
The behavioral educational intervention was grounded in Bandura's Self-Efficacy Theory and incorporated educational and lifestyle domains relevant to PCOS self-management. The program consisted of five structured sessions of approximately 60 minutes each. The sessions addressed understanding PCOS and self-management; healthy dietary practices; physical activity, sedentary behavior, and weight and waist management; metformin adherence, metabolic health, and symptom monitoring; and sleep, stress management, problem solving, and maintenance of behavioral changes. Individualized education, practical examples, achievable goals, self-monitoring, reinforcement, and follow-up contacts were incorporated to support behavioral change.
Clinical and laboratory assessments were performed at baseline and at six months. The primary objective was to compare changes from baseline to six months among the three study groups in anthropometric parameters, metabolic parameters, vitamin B12, iron-status biomarkers, erythropoietin, and hematological indices. Metabolic assessments included measures of glucose regulation and insulin resistance and lipid parameters. Iron-status assessments included serum iron, total iron-binding capacity, transferrin saturation, and ferritin. 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, differential leukocyte counts, and platelet count.
A secondary objective was to evaluate changes in PCOS-related knowledge and lifestyle practices among participants receiving the combined metformin and theory-based behavioral educational intervention. Knowledge domains included the definition of PCOS, causes and risk factors, signs and symptoms, complications, and treatment and management. Lifestyle domains included dietary practices, physical activity, leisure activities, and sleep.
The study was designed to provide a controlled comparison of routine care with matching placebo, metformin therapy, and metformin combined with structured behavioral education. Participants receiving the educational intervention could not be blinded to the educational component because they were aware of their participation in the program. Standardized procedures were used for clinical assessment, laboratory measurements, data collection, and statistical analysis.
- Conditions
- Polycystic Ovary Syndrome (PCOS) Women
- Being tested
- MetFORMIN, Matching Placebo, Theory-Based Behavioral Educational Program
- Keywords
- Metformin, PCOS, heory-Based Behavioral Education, Lifestyle Education, Vitamin B12, Iron Status, Erythropoietin, Metabolic Outcomes, Hematological Parameters
- Medical subject headings
- Polycystic Ovary Syndrome
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, given as 500 mg three times daily, for six months.
Matching PlaceboDrug
Matching placebo tablets identical to the metformin tablets in appearance, size, and form were administered for six months.
Theory-Based Behavioral Educational ProgramBehavioural
A structured behavioral educational program grounded in Bandura's Self-Efficacy Theory was provided to participants in the combined intervention group. The program consisted of five structured sessions addressing PCOS self-management, healthy dietary practices, physical activity and sedentary behavior, weight and waist management, metformin adherence, metabolic health, sleep, stress management, problem solving, and maintenance of behavioral changes.
| Study group | Role | What they receive |
|---|---|---|
| Matching Placebo Group | Active comparator | Participants received routine clinical care together with matching placebo tablets identical to the metformin tablets in appearance, size, and form for six months. They did not receive study-prescribed metformin or the structured theory-based behavioral educational intervention. Receives: Drug: Matching Placebo |
| Metformin Group | Experimental | Participants received routine clinical care together with metformin at a total daily dose of 1500 mg, administered as 500 mg three times daily, for six months. They did not receive the structured theory-based behavioral educational intervention. Receives: Drug: MetFORMIN |
| Metformin Plus Theory-Based Behavioral Education | Experimental | Participants received routine clinical care together with metformin at a total daily dose of 1500 mg, administered as 500 mg three times daily, for six months, plus a structured theory-based behavioral educational program. The program consisted of five structured sessions addressing PCOS self-management, healthy dietary practices, physical activity, sedentary behavior, weight and waist management, metformin adherence, metabolic health, sleep, stress management, problem solving, and maintenance of behavioral changes. Receives: Drug: MetFORMIN; Behavioral: Theory-Based Behavioral Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI) From Baseline to 6 Months
Change in body mass index (BMI) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Serum Insulin From Baseline to 6 Months
Change in serum insulin from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in HOMA-IR From Baseline to 6 Months
Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Total Cholesterol (TC) From Baseline to 6 Months
Change in total cholesterol (TC) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Triglycerides (TG) From Baseline to 6 Months
Change in triglycerides (TG) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to 6 Months
Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to 6 Months
Change in high-density lipoprotein cholesterol (HDL-C) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Serum Vitamin B12 From Baseline to 6 Months
Change in serum vitamin B12 concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Serum Iron From Baseline to 6 Months
Change in serum iron concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Serum Ferritin From Baseline to 6 Months
Change in serum ferritin concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Total Iron-Binding Capacity (TIBC) From Baseline to 6 Months
Change in total iron-binding capacity (TIBC) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Transferrin Saturation (TSAT) From Baseline to 6 Months
Change in transferrin saturation (TSAT) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Serum Erythropoietin (EPO) From Baseline to 6 Months
Change in serum erythropoietin (EPO) concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Hemoglobin (Hb) From Baseline to 6 Months
Change in hemoglobin (Hb) concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Hematocrit (Hct) From Baseline to 6 Months
Change in hematocrit (Hct) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Mean Corpuscular Volume (MCV) From Baseline to 6 Months
Change in mean corpuscular volume (MCV) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Mean Corpuscular Hemoglobin (MCH) From Baseline to 6 Months
Change in mean corpuscular hemoglobin (MCH) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) From Baseline to 6 Months
Change in mean corpuscular hemoglobin concentration (MCHC) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Red Cell Distribution Width (RDW) From Baseline to 6 Months
Change in red cell distribution width (RDW) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in White Blood Cell (WBC) Count From Baseline to 6 Months
Change in neutrophil count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Lymphocyte Count From Baseline to 6 Months
Change in lymphocyte count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Eosinophil Count From Baseline to 6 Months
Change in eosinophil count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Basophil Count From Baseline to 6 Months
Change in basophil count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Change in Platelet Count From Baseline to 6 Months
Change in platelet count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Measured: Baseline to 6 months
Secondary outcomes (1)
Change in PCOS-Related Knowledge and Lifestyle Practices From Baseline to 6 Months
Change from baseline to 6 months in PCOS-related knowledge and lifestyle-practice scores among participants receiving metformin combined with the theory-based behavioral educational program. The assessment included PCOS-related knowledge and lifestyle domains covering food habits, physical activity, leisure time, and sleep pattern.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1:1:1 ratio to three parallel groups: matching placebo, metformin, or metformin combined with a theory-based behavioral educational program. All groups received routine clinical care and were followed for six months.
- Masking
- None (open label)
- Enrolment
- 900 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
- NCT07811856
- Sponsor's protocol ID
- PCOS-MET-EDU-2025-01
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. Data will be retained by the research team and used for the purposes of the registered study and related scientific reporting.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Metformin Combined With a Theory-Based Educational Program on Metabolic, Vitamin B12, Iron Status, Erythropoietin, and Hematological Parameters Among Women With Polycystic Ovary Syndrome: A Three-Group Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07811856
- Acronym / sponsor ID
- PCOS-MET-EDU-2025-01
- Conditions
- Polycystic Ovary Syndrome (PCOS) Women
- Keywords
- Metformin, PCOS, heory-Based Behavioral Education, Lifestyle Education, Vitamin B12, Iron Status, Erythropoietin, Metabolic Outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Jerash Private UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 10 Sep 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.
Polycystic ovary syndrome (PCOS) is a common condition associated with metabolic abnormalities, including insulin resistance, impaired glucose regulation, and abnormal lipid levels. Metformin is commonly used to improve metabolic outcomes in women with PCOS, while lifestyle modification and behavioral education are important components of PCOS management. This study evaluates whether metformin, alone or combined with a theory-based behavioral educational program, is associated with changes in metabolic, vitamin B12, iron-status, erythropoietin, and hematological parameters compared with matching placebo.
This is a prospective, three-arm, parallel-group randomized controlled trial conducted among women aged 18-40 years with specialist-confirmed PCOS in Ministry of Health obstetrics and gynecology clinics in Jordan. A total of 900 participants were initially randomized in a 1:1:1 ratio to receive matching placebo, metformin, or metformin combined with a theory-based behavioral educational program. The metformin groups received 1500 mg/day, administered as 500 mg three times daily, for six months. The combined intervention group additionally received five structured educational sessions addressing PCOS self-management, healthy dietary practices, physical activity, weight and waist management, metformin adherence, sleep, stress management, problem solving, and maintenance of healthy behaviors.
Clinical and laboratory outcomes were assessed at baseline and after six months. The primary outcomes include changes in anthropometric, metabolic, vitamin B12, iron-status, erythropoietic, and hematological parameters. Changes in PCOS-related knowledge and lifestyle practices were also evaluated among participants receiving the combined intervention.
Detailed description
This study is a prospective, three-arm, parallel-group randomized controlled trial conducted among women diagnosed with polycystic ovary syndrome (PCOS). The study was conducted from August 2025 to February 2026 in obstetrics and gynecology clinics affiliated with the Ministry of Health, Jordan. The intervention and follow-up period lasted six months.
A total of 900 eligible participants were initially randomized in a 1:1:1 ratio to one of three study groups: a matching placebo group, a metformin group, and a combined metformin plus theory-based behavioral educational intervention group. All participants received routine clinical care for PCOS.
Participants assigned to the matching placebo group received routine clinical care together with matching placebo tablets identical to the metformin tablets in appearance, size, and form. Participants in the metformin group received routine clinical care together with metformin at a total daily dose of 1500 mg, administered as 500 mg three times daily, for six months. Participants in the combined intervention group received the same metformin regimen together with a structured theory-based behavioral educational program.
The behavioral educational intervention was grounded in Bandura's Self-Efficacy Theory and incorporated educational and lifestyle domains relevant to PCOS self-management. The program consisted of five structured sessions of approximately 60 minutes each. The sessions addressed understanding PCOS and self-management; healthy dietary practices; physical activity, sedentary behavior, and weight and waist management; metformin adherence, metabolic health, and symptom monitoring; and sleep, stress management, problem solving, and maintenance of behavioral changes. Individualized education, practical examples, achievable goals, self-monitoring, reinforcement, and follow-up contacts were incorporated to support behavioral change.
Clinical and laboratory assessments were performed at baseline and at six months. The primary objective was to compare changes from baseline to six months among the three study groups in anthropometric parameters, metabolic parameters, vitamin B12, iron-status biomarkers, erythropoietin, and hematological indices. Metabolic assessments included measures of glucose regulation and insulin resistance and lipid parameters. Iron-status assessments included serum iron, total iron-binding capacity, transferrin saturation, and ferritin. 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, differential leukocyte counts, and platelet count.
A secondary objective was to evaluate changes in PCOS-related knowledge and lifestyle practices among participants receiving the combined metformin and theory-based behavioral educational intervention. Knowledge domains included the definition of PCOS, causes and risk factors, signs and symptoms, complications, and treatment and management. Lifestyle domains included dietary practices, physical activity, leisure activities, and sleep.
The study was designed to provide a controlled comparison of routine care with matching placebo, metformin therapy, and metformin combined with structured behavioral education. Participants receiving the educational intervention could not be blinded to the educational component because they were aware of their participation in the program. Standardized procedures were used for clinical assessment, laboratory measurements, data collection, and statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly allocated in a 1:1:1 ratio to three parallel groups: matching placebo, metformin, or metformin combined with a theory-based behavioral educational program. All groups received routine clinical care and were followed for six months.
| Arm | Type | Receives |
|---|---|---|
| Matching Placebo Group | Active comparator | Drug: Matching PlaceboParticipants received routine clinical care together with matching placebo tablets identical to the metformin tablets in appearance, size, and form for six months. They did not receive study-prescribed metformin or the structured theory-based behavioral educational intervention. |
| Metformin Group | Experimental | Drug: MetFORMINParticipants received routine clinical care together with metformin at a total daily dose of 1500 mg, administered as 500 mg three times daily, for six months. They did not receive the structured theory-based behavioral educational intervention. |
| Metformin Plus Theory-Based Behavioral Education | Experimental | Drug: MetFORMIN, Behavioral: Theory-Based Behavioral Educational ProgramParticipants received routine clinical care together with metformin at a total daily dose of 1500 mg, administered as 500 mg three times daily, for six months, plus a structured theory-based behavioral educational program. The program consisted of five structured sessions addressing PCOS self-management, healthy dietary practices, physical activity, sedentary behavior, weight and waist management, metformin adherence, metabolic health, sleep, stress management, problem solving, and maintenance of behavioral changes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-40 years.
- Specialist-confirmed diagnosis of polycystic ovary syndrome (PCOS).
- Ability and willingness to participate in the six-month study follow-up.
- Ability to comply with the study procedures and assessments.
Key exclusion criteria (9 listed)
- Chronic hemolytic anemia.
- Chronic kidney disease.
- Hepatic disorders.
- Other endocrine, metabolic, or cardiovascular conditions that could affect glucose metabolism, vitamin B12 status, iron status, erythropoietin levels, or hematological parameters.
- Previous use of insulin-sensitizing medications other than the study metformin.
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, given as 500 mg three times daily, for six months. | Drug | Metformin Group, Metformin Plus Theory-Based Behavioral Education |
| Matching PlaceboMatching placebo tablets identical to the metformin tablets in appearance, size, and form were administered for six months. | Drug | Matching Placebo Group |
| Theory-Based Behavioral Educational ProgramA structured behavioral educational program grounded in Bandura's Self-Efficacy Theory was provided to participants in the combined intervention group. The program consisted of five structured sessions addressing PCOS self-management, healthy dietary practices, physical activity and sedentary behavior, weight and waist management, metformin adherence, metabolic health, sleep, stress management, problem solving, and maintenance of behavioral changes. | Behavioural | Metformin Plus Theory-Based Behavioral Education |
Primary outcome
Change in Body Mass Index (BMI) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in body mass index (BMI) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Serum Insulin From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in serum insulin from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in HOMA-IR From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Total Cholesterol (TC) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in total cholesterol (TC) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Triglycerides (TG) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in triglycerides (TG) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in low-density lipoprotein cholesterol (LDL-C) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in high-density lipoprotein cholesterol (HDL-C) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Serum Vitamin B12 From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in serum vitamin B12 concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Serum Iron From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in serum iron concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Serum Ferritin From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in serum ferritin concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Total Iron-Binding Capacity (TIBC) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in total iron-binding capacity (TIBC) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Transferrin Saturation (TSAT) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in transferrin saturation (TSAT) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Serum Erythropoietin (EPO) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in serum erythropoietin (EPO) concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Hemoglobin (Hb) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in hemoglobin (Hb) concentration from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Hematocrit (Hct) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in hematocrit (Hct) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Mean Corpuscular Volume (MCV) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in mean corpuscular volume (MCV) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Mean Corpuscular Hemoglobin (MCH) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in mean corpuscular hemoglobin (MCH) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in mean corpuscular hemoglobin concentration (MCHC) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Red Cell Distribution Width (RDW) From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in red cell distribution width (RDW) from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in White Blood Cell (WBC) Count From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in neutrophil count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Lymphocyte Count From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in lymphocyte count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Eosinophil Count From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in eosinophil count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Basophil Count From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in basophil count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
Change in Platelet Count From Baseline to 6 Months
Time frame: Baseline to 6 months
Change in platelet count from baseline to 6 months among participants assigned to the matching placebo, metformin, or metformin plus theory-based behavioral education groups.
1 secondary outcome
Change in PCOS-Related Knowledge and Lifestyle Practices From Baseline to 6 Months
Time frame: Baseline to 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 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. Data will be retained by the research team and used for the purposes of the registered study and related scientific reporting.
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Polycystic Ovary Syndrome (PCOS) Women
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 and Theory-Based Behavioral Educational Program 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 4 inclusion and 9 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 10 Sep 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 Body Mass Index (BMI) From Baseline to 6 Months (time frame: Baseline to 6 months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.