NCT07811856CompletedPhase 4
Effects of Metformin and Theory-Based Education in Women With Polycystic Ovary Syndrome
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 900 (actual)
- First submitted
- 4 Sept 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Jerash Private University
- NCT number
- NCT07811856
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 900
- From 1 Aug 2026 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous use of insulin-sensitizing medications other than the study metformin.
- Current or recent hormonal therapy that could affect the study outcomes.
Other illness
- Chronic kidney disease.
- Hepatic disorders.
- Any condition that could interfere with adherence to the intervention or completion of the six-month follow-up.
Lab values
- Other endocrine, metabolic, or cardiovascular conditions that could affect glucose metabolism, vitamin B12 status, iron status, erythropoietin levels, or hematological parameters.
- Use of medications that could substantially affect glucose metabolism, vitamin B12 status, iron status, erythropoietin levels, or hematological parameters.
Other
- Chronic hemolytic anemia.
- Current use of iron or vitamin B12 supplements.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jerash University Coordinator of this site? Confirm its status | Amman | Jordan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.