Primary outcomeNumber· baseline to week 24
Dose of Triptorelin for Ovarian Suppression
| Group | Value (μg/kg) |
|---|---|
| Placebo | NA |
| Triptorelin (T1-T4) | 120 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataTriptorelin for Ovary Protection in Childhood Onset Lupus
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 31 participants (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Other
- Design
- Randomized · Triple masking
- Countries
2 countries
United States, Brazil
- Start
- Jun 2003
- Primary completion
- Mar 2014
- Completion
- Mar 2014
- First posted
- 28 Jul 2005 (estimated)
- Last update posted
- 5 Jan 2021
- Conditions
- Systemic Lupus Erythematosus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200420062008201020122014
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- Triptorelin pamoateDrug
- Triptorelin PamoateDrug
- Triptorelin PamoateDrug
- Triptorelin PamoateDrug
- placeboOther
Arms5
Experimental
Triptorelin T1
Triptorelin Pamoate 25 μg/kg body weight
Experimental
Triptorelin T2
Triptorelin Pamoate 50 μg/kg body weight
Experimental
Triptorelin T3
Triptorelin Pamoate 75 μg/kg body weight T3
Experimental
Triptorelin T4
Triptorelin Pamoate 100 μg/kg body weight T4
Placebo comparator
Placebo
Normal Saline
Primary outcomes1
Outcomes the sponsor listed as primary.
Dose of Triptorelin for Ovarian Suppression
Time frame · baseline to week 24
Registry description
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 outcomes(1)
Length of Time of Triptorelin Treatment to Achieve Ovarian Suppression
Time frame · baseline to week 24
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMedian· baseline to week 24
Length of Time of Triptorelin Treatment to Achieve Ovarian Suppression
| Group | Value (days) |
|---|---|
| Placebo | NA |
| Triptorelin | 18 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo GroupNormal Saline placebo: placebo 0.9% normal saline IM injection | 0 / 6 | 3 / 6 | 3 / 6 |
| TriptorelinTriptorelin Pamoate Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis. | 0 / 25 | 4 / 25 | 6 / 25 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2015
4 results
Randomized, double-blind, dose-escalation trial of triptorelin for ovary protection in childhood-onset systemic lupus erythematosus.
Brunner et al. 2015Arthritis & rheumatology (Hoboken, N.J.)cited by 22
PMID 25676588PMC4414812DOI 10.1002/art.39024PUB-25676588
Rights unknown4 results
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 9 Years up to 21 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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