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Study · Randomized controlled trial · n = 31 · 2015

4 results

Randomized, double-blind, dose-escalation trial of triptorelin for ovary protection in childhood-onset systemic lupus erythematosus.

Brunner HI, Silva CA, Reiff A, Higgins GC, Imundo L, Williams CB, Wallace CA, Aikawa NE, Nelson S, Klein-Gitelman MS, Rose SR

Arthritis & rheumatology (Hoboken, N.J.)1 May 2015Cited by 22 (Europe PMC)

PMID25676588 (opens in a new tab)PMCIDPMC4414812 (opens in a new tab)DOI10.1002/art.39024 (opens in a new tab)PepBankPUB-25676588
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In female patients with childhood-onset SLE, triptorelin at 120 μg/kg sustained complete ovarian suppression in 90% of patients.

    In plain wordsIn girls with lupus, triptorelin at the reported dose maintained complete ovarian suppression in 90% of patients.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    Not applicableSustained complete ovarian suppression
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    120 μg/kg body weightAs given in this study (human).

    Measurements

    Complete ovarian suppression
    90%
    triptorelin 120 μg/kg

    Source sentences

    Summary
    Treatment with triptorelin at a weight-adjusted dose of 120 μg/kg body weight provided sustained complete ovarian suppression in 90% of the patients.
    2 context sentences
    Summary · context
    The primary outcome was the weight-adjusted dose of triptorelin that provided complete ovarian suppression in at least 90% of the patients, as determined by gonadotropin-releasing hormone agonist stimulation testing.
    Summary · context
    In this randomized, double-blind, placebo-controlled, dose-escalation study, female patients ages <21 years were randomized 4:1 to receive triptorelin (n = 25) or placebo (n = 6).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In female patients with childhood-onset SLE, complete ovarian suppression required 22 days after the initial triptorelin dose.

    In plain wordsIn girls with lupus, complete ovarian suppression required 22 days after the first triptorelin dose.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    Not applicableTime to complete ovarian suppression
    Study

    n = 25

    Analysis
    Secondary
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    Dose not stated

    Measurements

    Time to ovarian suppression
    22 days
    after initial triptorelin dose

    Source sentences

    Summary
    After administration of the initial dose of triptorelin, 22 days were required to achieve complete ovarian suppression.
    2 context sentences
    Summary · context
    The secondary outcome was the period of time required to achieve ovarian suppression, as measured by unstimulated follicle-stimulating hormone and luteinizing hormone levels after the initiation of triptorelin treatment.
    Summary · context
    In this randomized, double-blind, placebo-controlled, dose-escalation study, female patients ages <21 years were randomized 4:1 to receive triptorelin (n = 25) or placebo (n = 6).
  3. 03HumanRandomized controlled trialSafety outcome

    In female patients with childhood-onset SLE, adverse event rates were not higher with triptorelin than placebo: 189 versus 362 per 100 patient-months.

    In plain wordsIn girls with lupus, adverse event rates were not higher with triptorelin than placebo.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    No significant changeAdverse event rate
    Study

    n = 31

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Adverse event rate
    189 per 100 patient-months
    triptorelin group
    Adverse event rate
    362 per 100 patient-months
    placebo group

    Source sentences

    Summary
    The rates of adverse events (AEs) and serious adverse events (SAEs) per 100 patient-months of followup were not higher in the triptorelin group compared with the placebo group (for AEs, 189 versus 362; for SAEs, 2.1 versus 8.5).
    1 context sentence
    Summary · context
    In this randomized, double-blind, placebo-controlled, dose-escalation study, female patients ages <21 years were randomized 4:1 to receive triptorelin (n = 25) or placebo (n = 6).
  4. 04HumanRandomized controlled trialSafety outcome

    In female patients with childhood-onset SLE, serious adverse event rates were not higher with triptorelin than placebo: 2.1 versus 8.5 per 100 patient-months.

    In plain wordsIn girls with lupus, serious adverse event rates were not higher with triptorelin than placebo.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    No significant changeSerious adverse event rate
    Study

    n = 31

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Measurements

    Serious adverse event rate
    2.1 per 100 patient-months
    triptorelin group
    Serious adverse event rate
    8.5 per 100 patient-months
    placebo group

    Source sentences

    Summary
    The rates of adverse events (AEs) and serious adverse events (SAEs) per 100 patient-months of followup were not higher in the triptorelin group compared with the placebo group (for AEs, 189 versus 362; for SAEs, 2.1 versus 8.5).
    1 context sentence
    Summary · context
    In this randomized, double-blind, placebo-controlled, dose-escalation study, female patients ages <21 years were randomized 4:1 to receive triptorelin (n = 25) or placebo (n = 6).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT00124514

Triptorelin for Ovary Protection in Childhood Onset Lupus

Children's Hospital Medical Center, Cincinnatin = 31Jun 2003 to Mar 2014

Systemic Lupus Erythematosus

Trial pageClinicalTrials.govUpdated 5 Jan 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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