Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Triptorelin for Ovary Protection in Childhood Onset Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00124514
Recruitment Status : Completed
First Posted : July 28, 2005
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
Watson Pharmaceuticals
Information provided by (Responsible Party):
Hermine Brunner, MD, Children's Hospital Medical Center, Cincinnati

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


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Triptorelin pamoate Drug: Triptorelin Pamoate Other: placebo Phase 2

Detailed Description:

Lupus is an autoimmune disease that may harm all organs in the body and especially affects the kidney, brain, skin and lungs. Cyclophosphamide is a very effective medication to treat lupus, but it can damage the ovaries (pair of reproductive organs).

Only female lupus patients may participate in this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Triptorelin for Ovary Protection in Childhood Onset Lupus
Study Start Date : June 2003
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Triptorelin T1
Triptorelin Pamoate 25 μg/kg body weight
Drug: Triptorelin pamoate
IM injection given monthly
Other Name: Trelstar Depot

Experimental: Triptorelin T2
Triptorelin Pamoate 50 μg/kg body weight
Drug: Triptorelin Pamoate
IM injection given monthly
Other Name: Trelstar Depot

Experimental: Triptorelin T3
Triptorelin Pamoate 75 μg/kg body weight T3
Drug: Triptorelin Pamoate
IM injection given monthly
Other Name: Trelstar Depot

Experimental: Triptorelin T4
Triptorelin Pamoate 100 μg/kg body weight T4
Drug: Triptorelin Pamoate
IM injection given monthly
Other Name: Trelstar Depot

Placebo Comparator: Placebo
Normal Saline
Other: placebo
placebo 0.9% normal saline IM injection
Other Name: placebo 0.9% normal saline




Primary Outcome Measures :
  1. Dose of Triptorelin for Ovarian Suppression [ Time Frame: baseline to week 24 ]
    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.


Secondary Outcome Measures :
  1. Length of Time of Triptorelin Treatment to Achieve Ovarian Suppression [ Time Frame: baseline to week 24 ]
    Time to ovarian suppression, based on suppressed LH levels, after the initial dose of triptorelin. Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Acutely life-threatening disease activity that prohibits inclusion in a clinical trial
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124514


Locations
Layout table for location information
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Morgan Stanley Children's Hospital of New York
New York, New York, United States, 10032
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Columbus Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oklahoma
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Brazil
University of Sao Paulo
São Paulo, Brazil
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Watson Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Hermine I Brunner, M.D. M.Sc. Children's Hospital Medical Center, Cincinnati
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hermine Brunner, MD, Principal Investigator, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00124514    
Obsolete Identifiers: NCT00088244
Other Study ID Numbers: 2008-1045
FD-R-00239 ( Other Grant/Funding Number: FDA OOPD )
First Posted: July 28, 2005    Key Record Dates
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021
Last Verified: December 2020
Keywords provided by Hermine Brunner, MD, Children's Hospital Medical Center, Cincinnati:
SLE
Lupus
Ovarian damage
Menopause
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents