Trial · Interventional

CompletedPhase 3Results postedRegistry data

Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

NCTNCT00667446Other idL-CP07-177

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 72 participants (actual)
Sponsor: AbbVie (prior sponsor, Abbott) · Industry
Design: Not randomized · Open label (no masking)
Countries: 2 countries
United States, Puerto Rico
Start: Dec 2008
Primary completion: Oct 2012
Completion: Jan 2013
First posted: 28 Apr 2008 (estimated)
Last update posted: 9 Jan 2014 (estimated)
Conditions: Precocious · Leuprolide Acetate · Luteinizing Hormone (LH) · Gonadotrophin-releasing Hormone Agonist (GnRHa) · Tanner Staging · Depot Formulation · Suppression of LH · Central Precocious Puberty (CPP) · Gonadotrophin-releasing Hormone (GnRH) · Lupron · GnRH Analog · Pediatrics Central Precocious Puberty

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008200920102011201220132014

Ph 3
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
NCT00667446
Dec 2008 to Jan 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).

Interventions

Leuprolide Acetate 3 Month DepotDrug

Arms2

Experimental
Leuprolide Acetate 3M Depot 11.25 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months (3M) apart.
Experimental
Leuprolide Acetate 3M Depot 30 mg
Twelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone
Time frame · Day 1, Months 6, 12, 24, and 36
Registry description
Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \< 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.

Secondary outcomes(8)

Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)
Time frame · Day 1, Months 3, 6, 9, 12, and 24
Registry description
The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol \< 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed before this change occurred, with an LLOQ of 1 pg/mL. Final visit is the participant's last visit closest to Month 36.
Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)
Time frame · Months 6, 9, 12, 24, 30, and 36
Registry description
The percentage of female participants with suppression of basal estradiol to prepubertal levels, defined as estradiol \< 20 pg/mL. The estradiol assay was changed in June of 2010, and the lower limit of quantitation (LLOQ) was increased from 1 pg/mL to 10 pg/mL. This outcome measure reports data for assays performed after this change occurred, with an LLOQ of 10 pg/mL. Final visit is the participant's last visit closest to Month 36.
Percentage of Male Participants With Suppression of Basal Testosterone
Time frame · Day 1, Months 3, 6, 9, 12, 24, 30, and 36
Registry description
The percentage of male participants with suppression of basal testosterone to prepubertal levels, defined as testosterone \< 30 ng/dL. Final visit is the participant's last visit closest to Month 36.
Mean Peak-stimulated Luteinizing Hormone Concentration by Visit
Time frame · Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36
Registry description
Peak-stimulated luteinizing hormone refers to the maximum luteinizing hormone concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Final visit is the participant's last visit closest to Month 36.
Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)
Time frame · Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
Registry description
The percentage of female participants with suppression of breast development. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression of breast development is defined as regression or no progression of breast development from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.
Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)
Time frame · Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36
Registry description
The percentage of male participants with suppression of testicular volume and genital staging. Testicular volume was calculated from the length, width and height of each testicle measured by ultrasound. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a modified Tanner Staging pictogram. Suppression is defined as regression or no progression in both testicular volume and genital staging from Baseline (of the lead-in study L-CP07-167) according to pubertal staging. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Final visit is the participant's last visit closest to Month 36.
Change From Baseline in Growth Rate
Time frame · Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36
Registry description
Baseline growth rate was the growth rate in the one year prior to Day 1 of the lead-in study L-CP07-167. Growth rates were calculated as the ratio of the change in height to the change in chronological age with an approximate 6-month interval for Day 1, Months 6, 12, 18, 24, 30, 36 and the Final Treatment Visit.
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age
Time frame · Baseline (of the lead-in study L-CP07-167), and Day 1, Months 12, 24, and 36
Registry description
Bone age was determined by left hand/wrist bone age radiographs that were evaluated using the Fels Method by a central reader. The ratio of change from Baseline in bone age (BA)/change from Baseline in chronological age (CA) was calculated using the following formula: (BA at Post-baseline Treatment Visit - BA at Baseline) / (CA at Post-baseline Treatment Visit - CA at Baseline).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 1, Months 6, 12, 24, and 36

Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone

Group	Value (percentage of participants)
Leuprolide Acetate 3M Depot 11.25 mg	96.9
Leuprolide Acetate 3M Depot 30 mg	100.0

Secondary and other outcome results(7)

Secondary outcomeNumber· Day 1, Months 3, 6, 9, 12, and 24

Percentage of Female Participants With Suppression of Basal Estradiol (Assay 1)

Group	Value (percentage of participants)
Leuprolide Acetate 3M Depot 11.25 mg	96.4
Leuprolide Acetate 3M Depot 30 mg	100.0

Secondary outcomeNumber· Months 6, 9, 12, 24, 30, and 36

Percentage of Female Participants With Suppression of Basal Estradiol (Assay 2)

Group	Value (percentage of participants)
Leuprolide Acetate 3M Depot 11.25 mg	100.0
Leuprolide Acetate 3M Depot 30 mg	83.3

Secondary outcomeNumber· Day 1, Months 3, 6, 9, 12, 24, 30, and 36

Percentage of Male Participants With Suppression of Basal Testosterone

Group	Value (percentage of participants)
Leuprolide Acetate 3M Depot 11.25 mg	100.0
Leuprolide Acetate 3M Depot 30 mg	100.0

Secondary outcomeMean· Baseline of the lead-in study L-CP07-167, Day 1, Months 6, 12, 24, and 36

Mean Peak-stimulated Luteinizing Hormone Concentration by Visit

Group	Value (mIU/mL)	Spread
Leuprolide Acetate 3M Depot 11.25 mg	21.89	38.46
Leuprolide Acetate 3M Depot 30 mg	10.16	12.66

Secondary outcomeNumber· Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36

Percentage of Female Participants With Suppression of the Physical Signs of Puberty (Breast Development)

Group	Value (percentage of participants)
Leuprolide Acetate 3M Depot 11.25 mg	90.3
Leuprolide Acetate 3M Depot 30 mg	83.9

Secondary outcomeNumber· Baseline (of the lead-in study L-CP07-167), Day 1, Months 3, 6, 9, 12, 18, 24, 30, and 36

Percentage of Male Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development)

Group	Value (percentage of participants)
Leuprolide Acetate 3M Depot 11.25 mg	50.0
Leuprolide Acetate 3M Depot 30 mg	40.0

Secondary outcomeMean· Baseline (the 1 year prior to the start of treatment in the lead-in study), and Day 1, Months 6, 12, 18, 24, 30, and 36

Change From Baseline in Growth Rate

Group	Value (cm/year)	Spread
Leuprolide Acetate 3M Depot 11.25 mg	7.2	3.96
Leuprolide Acetate 3M Depot 30 mg	7.53	2.81

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Leuprolide Acetate 3M Depot 11.25 mgTwelve intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 months apart.	–	1 / 34	31 / 34
Leuprolide Acetate 3M Depot 30 mgTwelve intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 months apart.	–	0 / 38	31 / 38

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

8 results

36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty.

Lee et al. 2014The Journal of clinical endocrinology and metabolismcited by 34

PMID 24926950DOI 10.1210/jc.2013-4471PUB-24926950

Full text at the publisher8 results

Publisher page See results (8)

Eligibility

Who could join, as posted.

Sex: All
Age: Not stated
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Subject completed the Treatment Period of the lead-in study, L-CP07-167 (NCT00635817), and has documented luteinizing hormone suppression as evidenced by peak-stimulated luteinizing hormone \<4 mIU/mL at the Month 6 study visit of the lead-in study. * Demonstrated suppression of the physical signs of puberty at Month 6 of the lead-in study. * Subject is expected to receive at least 12 months of therapy to treat Central Precocious Puberty after study entry. * In general good health with no uncontrolled, clinically significant disease which would interfere with bone maturation or mask the objectives of this protocol as assessed by the investigator. Exclusion Criteria: * Incomplete precocious puberty, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma. * Bone age ≥14 years for girls and ≥15 years for boys (based on the Month 6 lead in study, L-CP07-167, radiographic results). * Has an abnormal laboratory value suggesting a clinically significant underlying disease or condition. * Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis. * Current therapy with medroxyprogesterone acetate. * Current therapy with growth hormone. * Current therapy with insulin-like growth factor-1 (IGF-1). * Current use of an estrogen preparation. * Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance. * Subject has a positive pregnancy test.

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