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Study on Slowing Advanced Puberty in Girls Using Metformin, Pioglitazone, and Spironolactone

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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 girls with advanced puberty and accelerated bone maturation, as well as those with Polycystic Ovary Syndrome (PCOS). The treatment being tested is a medication called SPIOMET, which is a combination of three active substances: metformin, pioglitazone, and spironolactone. These substances are commonly used to manage conditions related to insulin resistance and hormonal imbalances. The purpose of the study is to determine if this combination can help slow down the rapid maturation process in young girls who have experienced low birth weight and high weight gain after birth.

Participants in the study will be randomly assigned to receive either the SPIOMET treatment or a placebo. The study will last for a period of 12 months, during which the participants will take the medication in tablet form. Throughout the study, various health parameters will be monitored, including bone development, weight, height, and hormone levels. The study aims to observe any changes in these parameters to assess the effectiveness of the treatment.

In addition to monitoring physical changes, the study will also evaluate the safety of the treatment by checking blood tests and other health markers. The goal is to ensure that the treatment is not only effective but also safe for the participants. The study will provide valuable insights into managing conditions related to early puberty and PCOS in young girls, potentially leading to better treatment options in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria such as age, birth weight, and pubertal development stage.

    A physical examination is conducted, including measurements of height, weight, and body mass index (BMI). Blood samples may be taken to assess various health markers.

  2. Step 2

    Medication administration

    Participants receive the study medication, spiomet, which is a combination of metformin, pioglitazone, and spironolactone. The medication is administered orally in tablet form.

    The dosage and frequency of administration are determined by the study protocol and are explained during this step.

  3. Step 3

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor progress and assess the effects of the medication. These visits include physical examinations and may involve additional blood tests.

    Participants are asked about any side effects or changes in health status. Adherence to the medication regimen is also reviewed.

  4. Step 4

    Imaging and assessments

    Imaging tests, such as X-rays of the hand and wrist, are performed to evaluate bone age advancement. This helps in assessing the primary endpoint of the study.

    Additional assessments may include MRI scans to analyze abdominal and liver fat distribution.

  5. Step 5

    Final evaluation

    At the end of the study period, a final evaluation is conducted. This includes a comprehensive review of all collected data and health assessments.

    Participants are informed about the study's findings and any implications for their health.

Who can join the trial?

8 criteria

  • Girls aged between 8.0 and 9.5 years at the start of the study.
  • Born with a low birth weight for their gestational age, which means they were smaller than most babies born at the same number of weeks of pregnancy.
  • Have a high body mass index (BMI) for their age, which means they weigh more than most children their age.
  • Experiencing advanced puberty, which means they have started developing breasts (Tanner stage 2) between the ages of 7.7 and 9.3 years, and this development has been progressing for at least 2 months.
  • Of White ethnicity.
  • Born at term or late preterm, meaning they were born between 34 and 42 weeks of pregnancy.
  • Height at the first visit is between the 3rd and 97th percentile for their age and pubertal stage, meaning their height is within the normal range for their age and development.
  • Parents or legal guardians must provide written informed consent, which means they agree to let their child participate in the study after being fully informed about it.

Who cannot join the trial?

5 criteria

  • Girls who are not experiencing advanced puberty (a stage of development when a child's body begins to change into an adult body).
  • Girls who do not have accelerated bone maturation (when bones develop faster than normal).
  • Girls who do not have Polycystic Ovary Syndrome (PCOS) (a condition that affects a woman's hormone levels).
  • Girls who do not have a history of low prenatal weight (low weight before birth).
  • Girls who do not have a history of high postnatal weight (high weight after birth).
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Investigated drugs

Spiomet is a combination of medications used in this clinical trial to help slow down the rapid physical development in young girls who are going through puberty earlier than usual. This combination works by targeting different pathways in the body to reduce the amount of fat stored in places where it shouldn't be, which can happen when a girl has a low birth weight but gains a lot of weight after birth. By doing this, Spiomet aims to help manage the body's ability to store fat safely and reduce the speed of maturation.

What is already known about the treatment

Spiomet – Spiomet is administered orally in the form of a low-dose combination of generic medications. It is currently being studied in clinical trials to assess its effectiveness in slowing down accelerated maturation in early pubertal girls, particularly those with a history of low birth weight and high postnatal weight. The main therapeutic indications include conditions like advanced puberty and Polycystic Ovary Syndrome (PCOS) in girls. At the molecular level, Spiomet works by reducing ectopic fat through various pathways, which helps in managing lipid storage and reducing the speed of bone maturation. It falls under the pharmacological classification of medications that target fat metabolism and hormonal regulation.

Investigated diseases

Polycystic Ovary Syndrome (PCOS) – Polycystic Ovary Syndrome is a hormonal disorder common among women of reproductive age. It is characterized by irregular menstrual periods, excess androgen levels, and polycystic ovaries. The condition often leads to the development of small cysts on the ovaries. As the syndrome progresses, women may experience symptoms such as weight gain, acne, and thinning hair. The hormonal imbalance can also lead to difficulties with fertility. Over time, PCOS can contribute to long-term health issues like type 2 diabetes and heart disease.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-518675-55-00Protocol codeMINI-SPIOMETEstimated enrolment64 patientsSponsorHospital Universitari De Girona Doctor Josep Trueta

sourced from the EU Clinical Trials Register and site verification

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