Trials / Completed
CompletedNCT05029622
A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
A Phase III, Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Triptorelin Pamoate | Triptorelin 6-month formulation for IM on day 1 and Month 6. |
Timeline
- Start date
- 2021-08-10
- Primary completion
- 2022-08-21
- Completion
- 2023-02-13
- First posted
- 2021-08-31
- Last updated
- 2025-02-19
- Results posted
- 2024-05-28
Locations
14 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05029622. Inclusion in this directory is not an endorsement.