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Hormone Therapy

Assigned Intervention for Central Precocious Puberty

Phase 3
Waitlist Available
Research Sponsored by Tolmar Inc.
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 6 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Eligible Conditions
  • Central Precocious Puberty

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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 Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
Secondary study objectives
Bone Age Ratio to Chronological Age at Time of Measurement
Changes in Height Velocity (Growth Rate)
Percent Change From Baseline in Height
+7 more
Other study objectives
Bone Age
Bone Age Progression
Bone Age Ratio to Chronological Age at Start of Study
+6 more

Side effects data

From 2018 Phase 3 trial • 64 Patients • NCT02452931
22%
Nasopharyngitis
17%
Pyrexia
16%
Headache
13%
Cough
9%
Abdominal pain
8%
Nausea
6%
Constipation
6%
Upper respiratory tract infection
6%
Vomiting
6%
Bronchospasm
6%
Productive cough
2%
Wheezing
2%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Assigned Intervention

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Assigned InterventionExperimental Treatment1 Intervention
Leuprolide acetate 45 mg will be administered as a subcutaneous injection at 6-month intervals for the 12 month study period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide
FDA approved

Find a Location

Who is running the clinical trial?

Tolmar Inc.Lead Sponsor
4 Previous Clinical Trials
1,309 Total Patients Enrolled
Peggy SchorrStudy Directororphan reach USA, LLC
~6 spots leftby Dec 2025
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