Systemic Lupus ErythematosusPhase 2NCT00124514
Triptorelin for Ovary Protection in Childhood Onset Lupus
A Phase 2 study testing Triptorelin pamoate in people with Systemic Lupus Erythematosus, run by Children's Hospital Medical Center, Cincinnati at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 21 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Triptorelin pamoate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jun 2003to Mar 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Children's Memorial Hospital
Chicago, Illinois, 60614
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Columbus Children's Hospital
Columbus, Ohio, 43205
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Morgan Stanley Children's Hospital of New York
New York, New York, 10032
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73104
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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.
Read more
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
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Triptorelin pamoate, placebo
- Keywords
- SLE, Lupus, Ovarian damage, Menopause
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin pamoateDrug
Also called Trelstar Depot
IM injection given monthly
Triptorelin PamoateDrug
Also called Trelstar Depot
IM injection given monthly
Triptorelin PamoateDrug
Also called Trelstar Depot
IM injection given monthly
Triptorelin PamoateDrug
Also called Trelstar Depot
IM injection given monthly
placeboOther
Also called placebo 0.9% normal saline
placebo 0.9% normal saline IM injection
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin T1 | Experimental | Triptorelin Pamoate 25 μg/kg body weight Receives: Drug: Triptorelin pamoate |
| Triptorelin T2 | Experimental | Triptorelin Pamoate 50 μg/kg body weight Receives: Drug: Triptorelin Pamoate |
| Triptorelin T3 | Experimental | Triptorelin Pamoate 75 μg/kg body weight T3 Receives: Drug: Triptorelin Pamoate |
| Triptorelin T4 | Experimental | Triptorelin Pamoate 100 μg/kg body weight T4 Receives: Drug: Triptorelin Pamoate |
| Placebo | Placebo comparator | Normal Saline Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Triptorelin for Ovarian Suppression
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.
Measured: baseline to week 24
Secondary outcomes (1)
Length of Time of Triptorelin Treatment to Achieve Ovarian Suppression
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.
Measured: baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startJun 2003
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Watson Pharmaceuticals
- Responsible party
- Principal investigator, Hermine Brunner, MD, Children's Hospital Medical Center, Cincinnati
- Investigators
- Hermine I Brunner, M.D. M.Sc., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124514
- Sponsor's protocol ID
- 2008-1045
- Other IDs
- FD-R-00239
- Status last verified
- Dec 2020
- First submitted
- 26 Jul 2005
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Brunner HI, Silva CA, Reiff A, Higgins GC, Imundo L, Williams CB, Wallace CA, Aikawa NE, Nelson S, Klein-Gitelman MS, Rose SR. Randomized, double-blind, dose-escalation trial of triptorelin for ovary protection in childhood-onset systemic lupus erythematosus. Arthritis Rheumatol. 2015 May;67(5):1377-85. doi: 10.1002/art.39024.
PubMed 25676588
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triptorelin for Ovary Protection in Childhood Onset Lupus
- ClinicalTrials.gov ID
- NCT00124514
- Acronym / sponsor ID
- 2008-1045
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Lupus, Ovarian damage, Menopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Watson Pharmaceuticals
- Study start
- Jun 2003
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Jul 2005 (estimated)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Triptorelin T1 | Experimental | Drug: Triptorelin pamoateTriptorelin Pamoate 25 μg/kg body weight |
| Triptorelin T2 | Experimental | Drug: Triptorelin PamoateTriptorelin Pamoate 50 μg/kg body weight |
| Triptorelin T3 | Experimental | Drug: Triptorelin PamoateTriptorelin Pamoate 75 μg/kg body weight T3 |
| Triptorelin T4 | Experimental | Drug: Triptorelin PamoateTriptorelin Pamoate 100 μg/kg body weight T4 |
| Placebo | Placebo comparator | Other: placeboNormal Saline |
Who may qualify
- Ages
- 9 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin pamoateAlso: Trelstar DepotIM injection given monthly | Drug | Triptorelin T1 |
| Triptorelin PamoateAlso: Trelstar DepotIM injection given monthly | Drug | Triptorelin T2 |
| Triptorelin PamoateAlso: Trelstar DepotIM injection given monthly | Drug | Triptorelin T3 |
| Triptorelin PamoateAlso: Trelstar DepotIM injection given monthly | Drug | Triptorelin T4 |
| placeboAlso: placebo 0.9% normal salineplacebo 0.9% normal saline IM injection | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Length of Time of Triptorelin Treatment to Achieve Ovarian Suppression
Time frame: baseline to week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25676588Brunner HI, Silva CA, Reiff A, Higgins GC, Imundo L, Williams CB, Wallace CA, Aikawa NE, Nelson S, Klein-Gitelman MS, Rose SR. Randomized, double-blind, dose-escalation trial of triptorelin for ovary protection in childhood-onset systemic lupus erythematosus. Arthritis Rheumatol. 2015 May;67(5):1377-85. doi: 10.1002/art.39024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermine I Brunner, M.D. M.Sc. principal investigator
Children's Hospital Medical Center, Cincinnati
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triptorelin pamoate in people with Systemic Lupus Erythematosus, run by Children's Hospital Medical Center, Cincinnati at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Triptorelin for Ovarian Suppression (time frame: baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.