A study of Lupron Depot Lupron Depot in treatment of central premature puberty

• Register: EUCTR
• Last refreshed on: 1 December 2014
• Main ID: EUCTR2014-004495-36-Outside-EU/EEA
• Date of registration: 28/11/2014
• Prospective Registration: Yes
• Primary sponsor: Abbvie previously known as Abbott
• Public title: A study of Lupron Depot Lupron Depot in treatment of central premature puberty
• Scientific title: Study of Lupron Depot in the Treatment of Central Precocious Puberty
• Target sample size: 55
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004495-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: Abbott Laboratories

• Name: EU Clinical Trials Helpdesk
• Affiliation: Abbott Laboratories

Key inclusion & exclusion criteria

Inclusion criteria:
1. Clinical diagnosis of isosexual CPP with onset of Tanner scores of B2 (breast) or
P2 (pubic hair) earlier than age 8.0 years for girls or P2 (pubic hair) or G2
(genitalia) earlier than 9.0 years for boys.
2. Confirmation of diagnosis by a pubertal response to a GnRH stimulation test
(LH = 10 U/L at baseline).
3. Chronological age less than 9.0 years for girls or less than 10.0 years for boys at
entry into the study at the time of the first injection.
4. Bone age advanced at least one year beyond chronological age by Fels Method at
entry into the study.
5. This condition may have been idiopathic or secondary to another lesion. If
secondary, therapy of the primary condition had been undertaken and stabilized.
6. No evidence of abnormal pituitary, adrenal, thyroid, and gonadal function except
for premature secretion of gonadotropins.
7. In general good health with no uncontrolled, clinically significant disease that
would mask the objectives of this protocol.
8. All the prestudy procedures were completed.
9. Eligible for therapy for at least 1 year.
10. The parent/guardian voluntarily signed the informed consent after its content was
explained.
Are the trial subjects under 18? yes
Number of subjects for this age range: 55
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Irradiation to the central nervous system.
2. Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Central Precocious Puberty
MedDRA version: 17.1 Level: LLT Classification code 10073186 Term: Central precocious puberty System Organ Class: 100000004860

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Trade Name: trade name depends on the source of the product
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: LEUPRORELIN ACETATE
CAS Number: 74381-53-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-

Trade Name: trade name depends on the source of the product
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: LEUPRORELIN ACETATE
CAS Number: 74381-53-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15.0-

Primary Outcome(s)

Main Objective: The objective of the Phase 3 treatment period was to evaluate the safety and efficacy of leuprolide acetate for depot suspension in the treatment of CPP. Efficacy was evaluated based on Tanner staging and decrease of gonadotropins and sex steroids to prepubertal levels.

Secondary Objective: Not applicable

Primary end point(s): -Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Breast Development in Females)
-Percentage of Subjects (n/N) With Suppression of Clinical Sexual Characteristics According to Tanner Staging (Genital Development in Males)

Timepoint(s) of evaluation of this end point: Time Frame: Weeks 4, 8, 12, 24, 36, 48, then every 6 months until end of treatment, and end of treatment day

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: •Hormone laboratory test results (LH suppression). Time Frame: Weeks 4, 8, 12, 24, 36, 48, and then every 6 months until end of treatment, and end of treatment day.
•Ratio of change in bone age to the change in chronological age. Time Frame: Weeks 24 and 48 then every 12 months until end of treatment and end of treatment day.
•Predicted mature height. Time Frame: Weeks 24 and 48, then every 12 months until end of treatment, and end of treatment day.

Secondary end point(s): -Mean Peak Stimulated Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Concentrations
-Mean Stimulated Estradiol Concentrations in Females
-Mean Stimulated Testosterone Concentrations in Males
-Mean Ratio of Bone Age to Chronological Age

Secondary ID(s)

M90-516

Source(s) of Monetary Support

Abbvie previously known as Abbott