Triptorelin for Ovary Protection in Childhood Onset Lupus

This study has been completed.
Sponsor:
Collaborator:
Watson Pharmaceuticals
Information provided by (Responsible Party):
Hermine Brunner, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00124514
First received: July 26, 2005
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.

Funding Source: FDA OOPD and Watson Pharmaceuticals


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Triptorelin pamoate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Primary Outcome Measures:
  • To determine the dose of triptorelin that will maintain complete ovarian suppression between monthly injections [ Time Frame: Patients receive injections every 23-29 days ] [ Designated as safety issue: No ]
    Patients will receive monthly injections. Exact date and time is recorded. Information will be analyzed to determine length of suppression between injections


Secondary Outcome Measures:
  • To optimize the time interval at triptorelin injection and infusion of cyclophosphamide [ Time Frame: Monthly ] [ Designated as safety issue: No ]
    Data will be analyzed to determine best time to give triptorelin injection during cytoxan therapy.


Enrollment: 30
Study Start Date: June 2003
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triptorelin Vs Placebo (Normal Saline)
Placebo (Normal Saline) vs triptorelin Pamoate
Drug: Triptorelin pamoate
IM injection given monthly
Other Name: Trelstar Depot

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.

  Eligibility

Ages Eligible for Study:   9 Years to 21 Years
Genders 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124514

Locations
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 San Paulo
San Paulo, Brazil
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Watson Pharmaceuticals
Investigators
Principal Investigator: Hermine I Brunner, M.D. M.Sc. Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Hermine Brunner, Principal Investigator, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00124514     History of Changes
Obsolete Identifiers: NCT00088244
Other Study ID Numbers: 2008-1045, FD-R-00239
Study First Received: July 26, 2005
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
SLE
Lupus
Ovarian damage
Menopause

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Triptorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014