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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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.
| 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 |
| 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 |
- 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.
- 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.
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.
| Ages Eligible for Study: | 9 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
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
| 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 | |
| Principal Investigator: | Hermine I Brunner, M.D. M.Sc. | Children's Hospital Medical Center, Cincinnati |
| 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 |
|
SLE Lupus Ovarian damage Menopause |
|
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 |