Precocious puberty Trials in Disease

Study on Metformin and Lifestyle Changes for Girls with Early Puberty and Overweight

This trial is investigating how a medication called Metformin, along with lifestyle changes, might help manage early puberty in young girls who are also overweight. The study will run for six months and aims to understand whether these interventions can affect how quickly puberty progresses.

Who can participate:

• Girls between 8 and 9.5 years old
• Girls showing breast development at stage 2 or above on the Tanner scale during clinical examination
• Girls with specific hormone test results showing stimulated LH levels greater than 5 IU/L or non-stimulated LH levels greater than 3 IU/L
• Girls with a Body Mass Index above the 91st percentile or more than 1.34 standard deviations above average
• Girls who have not yet started menstruating

Who cannot participate:

• Girls who are not experiencing early puberty
• Girls who are not overweight
• Girls outside the specific age range
• Girls unable to follow study procedures
• Girls with medical conditions that might interfere with the study or make participation unsafe
• Girls taking medications that could affect study results
• Girls who have recently participated in another clinical trial

What the study involves: The main focus is on measuring bone age, which indicates how quickly a child's bones are maturing and serves as a marker of pubertal progression. Participants will be randomly assigned to receive either Metformin or a placebo (an inactive substance), and some will also participate in a lifestyle intervention program that includes changes in diet and physical activity.

Throughout the study, researchers will monitor breast development, sex hormone levels, body composition, fitness levels, blood pressure, heart rate, daily physical activity, and overall quality of life. The goal is to see whether Metformin and lifestyle changes can help manage early puberty and its associated challenges.

Investigational treatment: Metformin is the main medication being tested. It is commonly used to help control blood sugar levels and works by making the body more responsive to insulin. In this study, researchers want to see if it can also influence the progression of puberty. The lifestyle intervention focuses on healthier eating habits and increased physical activity to improve overall health and potentially affect pubertal development.

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

This trial is examining whether a combination medication called SPIOMET can help slow down rapid physical maturation in young girls with advanced puberty and accelerated bone development. The study particularly focuses on girls who were born with low birth weight but gained weight quickly after birth. The treatment period lasts for 12 months.

Who can participate:

• Girls aged between 8.0 and 9.5 years at the start of the study
• Girls born with low birth weight for their gestational age
• Girls with high body mass index for their age
• Girls experiencing advanced puberty who started developing breasts between ages 7.7 and 9.3 years, with development progressing for at least 2 months
• Girls of White ethnicity
• Girls born at term or late preterm (between 34 and 42 weeks of pregnancy)
• Girls whose height is between the 3rd and 97th percentile for their age and pubertal stage
• Parents or legal guardians must provide written informed consent

Who cannot participate:

• Girls who are not experiencing advanced puberty
• Girls who do not have accelerated bone maturation
• Girls who do not have Polycystic Ovary Syndrome
• Girls who do not have a history of low birth weight
• Girls who do not have a history of high weight gain after birth

What the study involves: The trial aims to assess whether SPIOMET can slow down the rapid maturation process by monitoring bone development, weight, height, and hormone levels over 12 months. Participants will be randomly assigned to receive either the SPIOMET treatment or a placebo. Regular follow-up visits will include physical examinations, blood tests, and imaging tests such as X-rays to evaluate bone age advancement and MRI scans to analyze body fat distribution.

The study also evaluates the safety of the treatment by monitoring various health markers throughout the trial period. The goal is to determine whether this treatment approach is both effective and safe for managing conditions related to early puberty and Polycystic Ovary Syndrome in young girls.

Investigational treatment: SPIOMET is a combination of three medications: metformin, pioglitazone, and spironolactone. These substances are commonly used to manage conditions related to insulin resistance and hormonal imbalances. The combination works by targeting different pathways in the body to reduce fat storage in areas where it shouldn't accumulate, which can help manage the body's ability to store fat safely and reduce the speed of physical maturation.

Summary

The two ongoing clinical trials for precocious puberty are taking place in different European countries: Denmark and Spain. Both studies focus exclusively on young girls experiencing early puberty, with particular attention to those who are overweight or have experienced specific birth and growth patterns.

Both trials share a common interest in using Metformin as part of the treatment approach, though the Spanish study combines it with additional medications in the SPIOMET formulation. The Danish study emphasizes the role of lifestyle interventions alongside medication, while the Spanish study focuses more on the medication combination itself. Both trials monitor bone age as a key indicator of pubertal progression and aim to slow down rapid physical maturation in young girls.

These studies represent important research efforts to better understand and manage early puberty, particularly in cases where it is associated with weight concerns or specific birth history factors. The trials are designed to provide insights into potential treatment options that may help families and healthcare providers address this condition more effectively.