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Study on Metformin and Metformin Hydrochloride for Overweight Adults with Polycystic Ovary Syndrome

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication Metformin in individuals with Polycystic Ovary Syndrome (PCOS). PCOS is a condition that affects women's hormone levels, leading to various symptoms such as irregular menstrual cycles, excess hair growth, and potential fertility issues. The study will compare two different daily doses of Metformin, 1500 mg and 2250 mg, to determine their effectiveness in managing the symptoms and biochemical markers associated with PCOS.

The purpose of the study is to find out if a lower dose of Metformin is as effective as a higher dose in improving health outcomes for women with PCOS. Participants will take the medication in the form of tablets, which are to be taken orally. The study will last for a period of 48 weeks, during which participants will be monitored for changes in weight, hormone levels, and any side effects such as nausea or abdominal pain. The study will also assess the impact of Metformin on menstrual regularity and overall quality of life.

Throughout the study, various health indicators will be measured, including weight, hormone levels like testosterone, and metabolic markers such as fasting glucose and insulin levels. The study aims to provide valuable insights into the optimal use of Metformin for managing PCOS, potentially leading to improved treatment strategies for women affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of polycystic ovary syndrome (PCOS), and body mass index (BMI) requirements.
Participants must be women aged 18-37 years with a BMI between 25 and 40 kg/m².
Step 2
Informed consent
Participants are required to sign an informed consent form, indicating their understanding and willingness to comply with the trial procedures.
Step 3
Randomization and medication allocation
Participants are randomly assigned to receive either 1500 mg or 2250 mg of metformin daily.
The medication is taken orally, and the dosage is divided into multiple doses throughout the day.
Step 4
Treatment phase
Participants begin the treatment phase, taking the assigned dose of metformin daily.
The treatment aims to evaluate the effects of different dosages on various health outcomes related to PCOS.
Step 5
Monitoring and assessments
Regular monitoring is conducted to assess primary and secondary endpoints, including weight, hormone levels, metabolic markers, and any gastrointestinal side effects.
Participants may undergo blood tests, questionnaires, and ultrasounds to evaluate these outcomes.
Step 6
Completion of trial
The trial is estimated to conclude by July 31, 2034.
Upon completion, participants may receive a summary of their individual results and the overall findings of the study.

Who can join the trial?

4 criteria

Women aged 18-37 years
A diagnosis of PCOS (Polycystic Ovary Syndrome) according to the updated 2023 International PCOS guideline
BMI (Body Mass Index) of 25 kg/m² or more, but less than 40 kg/m²
Signed informed consent and willingness to follow the trial procedures

Who cannot join the trial?

5 criteria

Individuals who are not between the ages of 18 and 37.
Individuals who are not overweight.
Individuals who do not have **polycystic ovary syndrome (PCOS)**. PCOS is a condition that affects a woman's hormone levels, often causing irregular periods and other symptoms.
Individuals who are not female, as the study is only for women.
Individuals who are part of a vulnerable population, which means people who might need special protection or care.

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Investigated drugs

Metformin is a medication commonly used to manage blood sugar levels in people with type 2 diabetes. In this trial, it is being studied for its potential benefits in treating polycystic ovary syndrome (PCOS) in overweight individuals. The trial aims to determine if different doses of metformin can improve biochemical and clinical outcomes for those with PCOS.

What is already known about the treatment

Metformin – Metformin is typically administered orally in tablet form. It is a well-established medication in medical literature, primarily used to manage blood sugar levels in individuals with type 2 diabetes. In this clinical trial, it is being studied for its effectiveness in treating polycystic ovary syndrome (PCOS), particularly in overweight individuals. Metformin works by decreasing glucose production in the liver and improving insulin sensitivity, which helps lower blood sugar levels. It belongs to the pharmacological class of biguanides.

Investigated diseases

Polycystic Ovary Syndrome – Polycystic Ovary Syndrome (PCOS) is a hormonal disorder common among women of reproductive age. It is characterized by irregular menstrual periods, excess androgen levels, and polycystic ovaries. Women with PCOS may experience symptoms such as hirsutism, acne, and alopecia due to elevated androgen levels. The condition can also lead to metabolic issues, including insulin resistance and weight gain. Ovarian morphology in PCOS often shows enlarged ovaries with numerous small cysts. The syndrome can affect menstrual cyclicity and overall quality of life.