Triptorelin for Ovary Protection in Childhood Onset Lupus (NCT00124514) | Clinical Trial Compass
CompletedPhase 2
Triptorelin for Ovary Protection in Childhood Onset Lupus
United States, Brazil31 participantsStarted 2003-06
Plain-language 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
Who can participate
Age range
9 Years – 21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 clinical…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose of Triptorelin for Ovarian Suppression
Timeframe: baseline to week 24
Trial details
NCT IDNCT00124514
SponsorChildren's Hospital Medical Center, Cincinnati