Triptorelin for Ovary Protection in Childhood Onset Lupus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00124514
• Date of registration: 26/07/2005
• Prospective Registration: No
• Primary sponsor: Children's Hospital Medical Center, Cincinnati
• Public title: Triptorelin for Ovary Protection in Childhood Onset Lupus
• Date of first enrolment: June 2003
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00124514
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
• Phase: Phase 2

Countries of recruitment

Brazil, United States

Contacts

• Name: Hermine I Brunner, M.D. M.Sc.
• Affiliation: Children's Hospital Medical Center, Cincinnati

Key inclusion & exclusion 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.



Age minimum: 9 Years
Age maximum: 21 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Triptorelin pamoate

Primary Outcome(s)

To determine the dose of triptorelin that will maintain complete ovarian suppression between monthly injections [Time Frame: Patients receive injections every 23-29 days]

Secondary Outcome(s)

To optimize the time interval at triptorelin injection and infusion of cyclophosphamide [Time Frame: Monthly]

Secondary ID(s)

2008-1045

FD-R-00239

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Watson Pharmaceuticals