A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

• Sponsor: AbbVie (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03695237
• Collaborator: (none)
• Enrollment: 45
• Locations: 21
• Arm: 1
• Anticipated Duration (Months): 60.7
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.

Condition or Disease	Intervention/Treatment	Phase
Central Precocious Puberty (CPP)	Drug: Leuprolide Acetate (LA)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)
• Actual Study Start Date: Oct 24, 2018
• Actual Primary Completion Date: May 17, 2021
• Anticipated Study Completion Date: Nov 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants receiving Leuprolide Acetate (LA) Participants with Central Precocious Puberty receiving LA	Drug: Leuprolide Acetate (LA); It is administered intramuscularly as an injection

Outcome Measures

Primary Outcome Measures

1. Part 1: Percentage of Participants with suppression of GnRHa-stimulated luteinizing hormone (LH)(<4 milli-international units per milliliter (mlU/mL)) [Up through Week 48]

   It is measured by peak LH stimulation test

Secondary Outcome Measures

1. Part 1: Percentage of female participants with suppression of basal estradiol to <20 pg/mL [Up to Week 48]

   Female participants with suppression of basal estradiol to < 20 pg/mL are assessed

2. Part 1: Percentage of male participants with suppression of testosterone to <30 ng/dL [Up to Week 48]

   Male participants with suppression of testosterone to < 30 ng/dL are assessed

3. Part 2: Percentage of participants with maintenance of suppression of GnRHa-stimulated LH (<4 mlU/mL) [Up to Week 144]

   Participants with maintenance of suppression of GnRHa-stimulated LH (<4 mlU/mL) are assessed

4. Part 2: Percentage of female participants with maintenance of suppression of basal estradiol to <20 pg/mL [Up to Week 144]

   Female participants with maintenance of suppression of basal estradiol to < 20 pg/mL are assessed

5. Part 2: Percentage of male participants with maintenance of suppression of testosterone to <30 ng/dL [Up to Week 144]

   Male participants with maintenance of suppression of testosterone to < 30 ng/dL are assessed

6. Part 2: Percentage of participants with suppression of the physical signs of puberty [Up to Week 144]

   Breast development in females, testicular volume or genital development in males will be assessed using modified Tanner staging.

7. Part 2: Incremental growth rate [Up to Week 144]

   Incremental growth rate (cm/year) will be assessed.

8. Part 2: Ratio of change from baseline in bone age vs chronological age [Up to Week 144]

   Ratio of change from baseline in bone age vs chronological age is assessed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age).

• No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Endocrinology Associates /ID# 200629	Long Beach	California	United States	90806-1651
2	Rady Children's Hospital San Diego /ID# 202491	San Diego	California	United States	92123
3	Children's Hospital Colorado /ID# 201645	Aurora	Colorado	United States	80045
4	Pediatric Endocrine Associates /ID# 201089	Greenwood Village	Colorado	United States	80111
5	Nemours Children's Health System /ID# 201331	Jacksonville	Florida	United States	32207
6	Arnold Palmer Hospital /ID# 201624	Orlando	Florida	United States	32806
7	Van Meter Pediatric Endocrinology /ID# 201688	Atlanta	Georgia	United States	30318-2538
8	Rocky Mountain Diabetes and Osteoporosis Center /ID# 209878	Idaho Falls	Idaho	United States	83404-7596
9	Indiana University /ID# 200526	Indianapolis	Indiana	United States	46202
10	Pediatric Endocrine Associates /ID# 202396	Boston	Massachusetts	United States	02114
11	UMass Chan Medical School /ID# 203327	Worcester	Massachusetts	United States	01655
12	University of Minnesota /ID# 200508	Minneapolis	Minnesota	United States	55455-0356
13	Children's Mercy Hospital and Clinics /ID# 200221	Kansas City	Missouri	United States	64108
14	UBMD - Pediatrics /ID# 201978	Buffalo	New York	United States	14203
15	The Mount Sinai Hospital /ID# 200675	New York	New York	United States	10029
16	University of Oklahoma /ID# 200659	Tulsa	Oklahoma	United States	74135-2527
17	Penn State Children's Hospital /ID# 200287	Hershey	Pennsylvania	United States	17033-2360
18	Children's Hospital of Philadelphia - Main /ID# 203846	Philadelphia	Pennsylvania	United States	19104-4319
19	Cook Children's Med. Center /ID# 212937	Fort Worth	Texas	United States	76104
20	MultiCare Institute Health System /ID# 202188	Tacoma	Washington	United States	98405
21	Pediatric Endocrine Research Associates /ID# 200131	San Juan		Puerto Rico	00935

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03695237
• Other Study ID Numbers: M16-904
• First Posted: Oct 4, 2018
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by AbbVie: Central Precocious Puberty (CPP); Leuprolide Acetate (LA)
• Additional relevant MeSH terms: Puberty, Precocious; Leuprolide

Study Results

No Results Posted as of Mar 31, 2022