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Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 1 of 12 entriesv20
  2. Study sites: 205 to 206v19
  3. Trial sites expanded: 193 → 205 locations Eligibility criteria expanded, about 142 words · Study description expanded, about 8 wordsv18 Show 2 more changesShow less
    • Eligibility criteria expanded, about 142 words
    • Study description expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial sites expanded: 187 → 193 locationsv17
  5. Study sites: 176 to 187v16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 153 to 176v15
  2. Study sites: 148 to 153v14
  3. Study sites: 141 to 148v13
  4. Study sites: 80 to 141 Eligibility criteria expanded, about 17 wordsv12 Show 1 more changeShow less
    • Eligibility criteria expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 73 to 80v11
  6. Study sites: 36 to 73 Start date changed from estimate of Mar 31, 2025 to Feb 27, 2025v10 Show 1 more changeShow less
    • Start date changed from estimate of Mar 31, 2025 to Feb 27, 2025
  7. Study sites: 35 to 36 Start date: Mar 13, 2025 to Mar 31, 2025v9 Show 1 more changeShow less
    • Start date: Mar 13, 2025 to Mar 31, 2025
  8. Start date: Feb 10, 2025 to Mar 13, 2025 Study sites: 30 to 35v8 Show 1 more changeShow less
    • Study sites: 30 to 35
  9. Study sites: 3 to 30v7
  10. Study sites: 2 to 3v6
  11. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v5 Show 1 more changeShow less
    • Study sites: 0 to 2
  12. Study Status, Study Descriptionv4
  13. Start date: Dec 18, 2024 to Feb 10, 2025 Secondary endpoints: details revised at 5 of 12 entriesv3 Show 1 more changeShow less
    • Secondary endpoints: details revised at 5 of 12 entries
  14. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.
Trial Details
NCT Number NCT06513962
Lead Sponsor Children's Oncology Group
Conditions Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov