Clinical trial • Phase II • Endocrinology
Metformin hydrochloride for Precocious puberty | Overweight
Phase II trial of Metformin hydrochloride for Precocious puberty | Overweight.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Precocious puberty | Overweight
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 27-02-2024
- First CTIS Authorization Date
- 30-04-2024
Trial design
Randomised, placebo to metformin zentiva 1000 mg scored tablet (placebo matching metformin zentiva 1000 mg; metformin product max daily dose reported as 1000 mg).-controlled Phase II trial in Denmark.
- Randomised
- Yes
- Comparator
- Placebo to Metformin Zentiva 1000 mg scored tablet (placebo matching Metformin Zentiva 1000 mg; metformin product max daily dose reported as 1000 mg).
- Target Sample Size
- 80
- Trial Duration For Participant
- 365
Eligibility
Recruits 80 paediatric patients.
- Vulnerable Population
- Participants are children (girls aged 8–9.5 years); vulnerable population selected. Informed consent materials and child information leaflets are listed (subject information and informed consent form and information leaflet for children), indicating consent will be obtained from parent(s)/legal guardian(s) with age-appropriate information/assent provided to the child.
Inclusion criteria
- {"criterion_text":"- •\tGirls aged 8-9.5 years\n- •\tBreast development on clinical examination (≥Tanner B2)\n- •\tGnRH test with stimulated LH>5 IU/l or non-stimulated LH>3 IU/L\n- •\tBMI > 91st percentile/+1.34 SDs\n- •\tPremenarcheal"}
Exclusion criteria
- {"criterion_text":"- •\tKnown or suspected hypersensitivity or allergy to Metformin\n- •\tDiabetes Mellitus (type 1 or 2)\n- •\tPrevious or active malignancy\n- •\tCardiac, pulmonary, hepatic, or renal diseases associated with significant decompensation\n- •\tPsychological problems likely to lead to significant non-compliance"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Changes in bone age over 1 year","definition_or_measurement_approach":"Change in bone age over 1 year as a marker of pubertal maturation (bone age used as marker of pubertal maturation)."}
Secondary endpoints
- {"endpoint_text":"- Breast development\n- Sex hormones\n- HOMA-IR (calculated from fasting insulin and glucose)\n- Metabolic markers\n- Body composition\n- Fitness level\n- Blood pressure and resting heart rate\n- Daily physical activity energy expenditure\n- Quality of Life\n- Age at menarche","definition_or_measurement_approach":"HOMA-IR: calculated from fasting insulin and glucose. Other endpoints: specific measurement approaches not specified in the provided registry data."}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent obtained from parent(s)/legal guardian(s); age-appropriate subject information and assent materials provided for children (subject information and informed consent form and child information leaflet documents are listed).
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 80
Denmark
- Earliest CTIS Part Ii Submission Date
- 25-04-2024
- Latest Decision Or Authorization Date
- 19-11-2025
- Processing Time Days
- 573
- Number Of Sites
- 5
- Number Of Participants
- 80
Sites
- Site Name
- Region Sjaelland
- Department Name
- Pediatrics
- Principal Investigator Name
- Annette Korsholm Mouritsen
- Principal Investigator Email
- akmo@regionsjaelland.dk
- Contact Person Name
- Annette Korsholm Mouritsen
- Contact Person Email
- akmo@regionsjaelland.dk
- Site Name
- Lillebaelt Hospital
- Department Name
- Pediatrics and Adolescent Medicine
- Principal Investigator Name
- Line Anker Bang Thybo
- Principal Investigator Email
- Line.Anker.Bang.Thybo@rsyd.dk
- Contact Person Name
- Line Anker Bang Thybo
- Contact Person Email
- Line.Anker.Bang.Thybo@rsyd.dk
- Site Name
- Herlev Hospital
- Department Name
- Pediatrics and adolescent medicine
- Principal Investigator Name
- Rikke Beck Jensen
- Principal Investigator Email
- rikke.beck.jensen@regionh.dk
- Contact Person Name
- Rikke Beck Jensen
- Contact Person Email
- rikke.beck.jensen@regionh.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- Pediatrics and Adolescent Medicine
- Principal Investigator Name
- Astrid Bruun Rasmussen
- Principal Investigator Email
- ASTRRA@rm.dk
- Contact Person Name
- Astrid Bruun Rasmussen
- Contact Person Email
- ASTRRA@rm.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Pediatrics
- Principal Investigator Name
- Ann-Margrethe Rønholt Christensen
- Principal Investigator Email
- amrc@rn.dk
- Contact Person Name
- Ann-Margrethe Rønholt Christensen
- Contact Person Email
- amrc@rn.dk
Sponsor
Primary sponsor
- Full Name
- Herlev Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Metformin "Zentiva", filmovertrukne tabletter
- Active Substance
- Metformin hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation in DK (marketingAuthNumber: 64429)
- Maximum Dose
- 1000 mg
- Investigational Product Name
- Placebo to Metformin Zentiva 1000 mg scored tablet
- Modality
- Other
- Authorisation Status
- Not applicable / placebo (no marketing authorisation specified)
- Combination Treatment
- Yes
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