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Gonadotropin-releasing Hormone Agonist

Triptorelin formulation for Intramuscular injection (IM). for Central Precocious Puberty

Phase 3
Waitlist Available
Research Sponsored by Ipsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at months 3, 6, 9 and 12
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).

Eligible Conditions
  • Central Precocious Puberty

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at months 3, 6, 9 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at months 3, 6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Luteinising Hormone (LH) Suppression
Secondary study objectives
Change From Baseline in BA:CA Ratio
Change From Baseline in Basal Serum LH and Follicle-Stimulating Hormone (FSH) Levels
Change From Baseline in Body Mass Index (BMI)
+13 more

Side effects data

From 2023 Phase 3 trial • 66 Patients • NCT05029622
47%
Upper respiratory tract infection
15%
COVID-19
14%
Pyrexia
14%
Weight increased
11%
Cough
11%
Overweight
6%
Suspected COVID-19
6%
Bronchitis
5%
Abdominal pain
5%
Rhinitis allergic
5%
Tonsillitis
5%
Rhinitis
5%
Obesity
3%
Mouth ulceration
3%
Asthenopia
3%
Vaginal haemorrhage
3%
Rhinorrhoea
3%
Urinary occult blood positive
3%
Hepatic steatosis
3%
Urticaria
3%
Respiratory tract infection
3%
Sinusitis
3%
Urinary tract infection
2%
Xerophthalmia
2%
Refraction disorder
2%
Leukocytosis
2%
Abdominal pain upper
2%
Constipation
2%
Anal fissure
2%
Influenza like illness
2%
Nocturnal emission
2%
Allergic cough
2%
Oropharyngeal pain
2%
Listless
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Eosinophil count increased
2%
Gamma-glutamyltransferase increased
2%
Liver function test abnormal
2%
Myoglobin blood increased
2%
Scratch
2%
Anaemia
2%
Diarrhoea
2%
Gastritis
2%
Nausea
2%
Vomiting
2%
Rash
2%
Dermatitis
2%
Eczema
2%
Haematuria
2%
Acarodermatitis
2%
Helicobacter infection
2%
Localised infection
2%
Nasopharyngitis
2%
Otitis media
2%
Acute sinusitis
2%
Gastroenteritis
2%
Hyperglycaemia
2%
Vitamin D deficiency
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Triptorelin formulation for Intramuscular injection (IM).Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triptorelin Pamoate
2003
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor
350 Previous Clinical Trials
74,259 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
260 Previous Clinical Trials
56,177 Total Patients Enrolled
~16 spots leftby Nov 2025
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