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Towards a treatment for accelerated maturation in girls testing spiomet.
EU CTIS ID: 2024-518675-55-00
What this study is testing
To determine whether a low-dose combination of generics that collectively reduce ectopic adiposity through different pathways can slow accelerated maturation in early pubertal girls with a history of low prenatal weight (resulting in reduced subcutaneous adipogenesis and reduced capacity for safe lipid storage) and high postnatal weight (resulting in more lipogenesis and more need for lipid storage).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age at baseline: 8,0 ≤ age ≤ 9,5 years
- Birth weight for gestational age (BW-GA) in lower tertile: -2,5 ≤ PN-EG Z-score ≤ 0
- Body mass index for chronological age at 1st visit in upper tercile: +0 ≤ BMI Z-score ≤ +2,5
- Progressive advanced puberty [bilateral breast development (Tanner stage 2)] of onset between 7,7 and 9,3 years, with a minimum of 2 months progression
- White ethnicity
- Term or late preterm pregnancy: 34 ≤ gestational age < 42 weeks
You likely can't join if
- Excessive delay or advancement of bone age (more than 2 years for chronological age). A bone age radiograph taken within the previous 3 months is acceptable for screening purposes. In this case, a new bone age radiograph should be taken within one week before or after the start of treatment.
- Any disease which, in the opinion of the investigator, compromises the inclusion of the subject in the clinical trial.
- Tanner's stage of breast development greater than 2.
- Twin pregnancy
- Obesity at the 1st visit (BMI Z-score above +2,5 for chronological age)
- Evidence of a pathological cause of rapid maturation (including but not limited to: congenital adrenal hyperplasia due to 21-hydroxylase deficiency)
See the full eligibility criteria
- Age at baseline: 8,0 ≤ age ≤ 9,5 years
- Birth weight for gestational age (BW-GA) in lower tertile: -2,5 ≤ PN-EG Z-score ≤ 0
- Body mass index for chronological age at 1st visit in upper tercile: +0 ≤ BMI Z-score ≤ +2,5
- Progressive advanced puberty [bilateral breast development (Tanner stage 2)] of onset between 7,7 and 9,3 years, with a minimum of 2 months progression
- White ethnicity
- Term or late preterm pregnancy: 34 ≤ gestational age < 42 weeks
- Height at 1st visit: 3rd percentile ≤ height ≤ 97th percentile (adjusted for pubertal stage)
- Written informed consent of parents or legal guardian.
- Excessive delay or advancement of bone age (more than 2 years for chronological age). A bone age radiograph taken within the previous 3 months is acceptable for screening purposes. In this case, a new bone age radiograph should be taken within one week before or after the start of treatment.
- Any disease which, in the opinion of the investigator, compromises the inclusion of the subject in the clinical trial.
- Tanner's stage of breast development greater than 2.
- Twin pregnancy
- Obesity at the 1st visit (BMI Z-score above +2,5 for chronological age)
- Evidence of a pathological cause of rapid maturation (including but not limited to: congenital adrenal hyperplasia due to 21-hydroxylase deficiency)
- Known genetic abnormality or chronic conditions, including cardiovascular, neurological, immunological, metabolic, renal, endocrine, digestive, respiratory, or oncological diseases
- Chronic use of medications, including but not limited to: anticoagulants, anti-inflammatory drugs, oral hypoglycaemics, antiandrogens, oestrogens, progestogens, glucocorticoids, digoxin. Only the use of paracetamol before or during the course of the study will be accepted.
- Acute infections or intake of antibiotics or anti-inflammatory drugs within the last 14 days. This criterion applies only to blood collections. Blood draws should be postponed for 14 days after the patient no longer has symptoms and stops taking any of these medications.
- Previous history of hypersensitivity to any of the medicinal products used in the clinical trial, or to their excipients.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.