Triptorelin for Ovary Protection in Childhood Onset Lupus
2 other identifiers
interventional
31
2 countries
10
Brief Summary
The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed. This study is currently being conducted at 3 sites across the United States and Brazil (Los Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this study. Each patient will be randomized (assigned) to one of 5 groups. Randomization means that patients are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group. This is a dose escalation study, each patient will receive the first dose of the study drug (T1 - T4, placebo). If a patient has complete ovarian suppression on day 27 after the initial injection of study drug, then she will remain on this weight-adjusted dose of study drug throughout the study. The dose will be increased up for a weight gain of 5kg or greater. The dose will not be adjusted downward for a weight loss. If COS was not maintained with the 1st dose of study drug, then the subsequently injected 2nd dose will be increased by 25% or at least 20 microgram/kg/dose. The maximal dose of 150 microgram/kg/dose will not be exceeded. The absolute maximum dose is 20 mg. Funding Source: FDA OOPD and Watson Pharmaceuticals
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2003
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 26, 2005
CompletedFirst Posted
Study publicly available on registry
July 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
January 5, 2021
CompletedJanuary 5, 2021
December 1, 2020
10.8 years
July 26, 2005
September 9, 2020
December 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose of Triptorelin for Ovarian Suppression
Dose escalation was initiated If COS was not maintained with the 1st dose of study drug. Subsequent doses were increased by 25% or at least 20μg/kg dose. This procedure of dose increases by 25% or at least 20μg/kg dose was repeated until COS was maintained. Absolute max dose 7.8mg. Triptorelin (T1-T4) groups were pooled for analysis.
baseline to week 24
Secondary Outcomes (1)
Length of Time of Triptorelin Treatment to Achieve Ovarian Suppression
baseline to week 24
Study Arms (5)
Triptorelin T1
EXPERIMENTALTriptorelin Pamoate 25 μg/kg body weight
Triptorelin T2
EXPERIMENTALTriptorelin Pamoate 50 μg/kg body weight
Triptorelin T3
EXPERIMENTALTriptorelin Pamoate 75 μg/kg body weight T3
Triptorelin T4
EXPERIMENTALTriptorelin Pamoate 100 μg/kg body weight T4
Placebo
PLACEBO COMPARATORNormal Saline
Interventions
Eligibility Criteria
You may qualify if:
- Females under the age of 21 and non-pregnant
- Tanner stage of 2 or above as determined by physical examination of breast stage
- Diagnosis with SLE using the updated American College of Rheumatology (ACR) Classification Criteria for SLE 1
- Severe SLE requiring cyclophosphamide therapy
- Bone mineral density z-score \> - 2.0
- Must be using a medically acceptable form of birth control during the study and must not be pregnant at the screening visit
- No clinically significant abnormal findings other than those consistent with the diagnosis of childhood-onset SLE (cSLE) on the physical examination, medical history or clinical laboratory results during screening
- Currently on any combination of medication but must not have been treated with more than one dose of cyclophosphamide or other gonadotoxic medications in the past
- Voluntary consent or, if under the age of consent, assent to participate in this study with permission by a legal guardian
You may not qualify if:
- Male patients of any age
- Female patients with a Tanner stage of 1
- Positive blood pregnancy test at screening or taking oral or injectable birth-control medications
- Prior exposure to more than one dose of gonadotoxic medications including cyclophosphamide
- History of allergic or adverse response to triptorelin
- Diagnosed with hypogonadism prior to cyclophosphamide exposure
- History of clinically significant gastrointestinal tract, renal, hepatic, endocrine, oncologic, pulmonary (asthma accepted), or cardiovascular disease; or a history of tuberculosis, epilepsy, diabetes, depression, psychosis, or any other non-cSLE condition, which in the opinion of the physician, would jeopardize the safety of the subject or impact the validity of the study results
- Patient age 18 years of younger with severe depression as defined by a CDI (Children's Depression Inventory) score of \> 23 or a patient age 19 to 21 years with severe depression as defined by a BDI (Beck's Depression Inventory) score \> 29
- Patient admits to suicidal thoughts at screening visit
- Bone mineral density lower than z = -2.0.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Morgan Stanley Children's Hospital of New York
New York, New York, 10032, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Columbus Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
University of Sao Paulo
São Paulo, Brazil
Related Publications (1)
Brunner HI, Silva CA, Reiff A, Higgins GC, Imundo L, Williams CB, Wallace CA, Aikawa NE, Nelson S, Klein-Gitelman MS, Rose SR. Randomized, double-blind, dose-escalation trial of triptorelin for ovary protection in childhood-onset systemic lupus erythematosus. Arthritis Rheumatol. 2015 May;67(5):1377-85. doi: 10.1002/art.39024.
PMID: 25676588DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hermine Brunner
- Organization
- cincinnatichildrens
Study Officials
- PRINCIPAL INVESTIGATOR
Hermine I Brunner, M.D. M.Sc.
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 26, 2005
First Posted
July 28, 2005
Study Start
June 1, 2003
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
January 5, 2021
Results First Posted
January 5, 2021
Record last verified: 2020-12