Triptorelin to Protect Ovaries During Cancer Treatment

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

Recruiting Phase 3 Interventional Study
Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
Up to 39
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
Children's Oncology Group · Research network
Who this trial is looking for

This trial is looking for young females with cancer who are about to start chemotherapy. It involves taking a medication called triptorelin to help protect the ovaries from damage caused by chemotherapy drugs.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a female under 40 years of age.
  • I have started my menstrual periods and my first period was more than 6 months ago.
  • I am newly diagnosed with my first cancer, not including breast cancer.
  • I will be treated with certain types of chemotherapy called alkylating agents.
  • I will complete my planned treatment within one year after joining.
  • I or my legal guardian have signed a consent form.

You may not be able to join if

  • I am planning to have radiation therapy to my pelvis.
  • I am scheduled to have my ovaries removed.
  • I have a congenital syndrome that affects my fertility.
  • I have a pre-existing seizure disorder or other specified serious health issues.
  • I received certain hormone treatments in the last 6 months.
  • I had chemotherapy more than 7 days before enrolling.
  • I am currently pregnant or breastfeeding.
  • I am sexually active and not using effective contraception.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * \< 40 years of age at the time of enrollment * Patient must be a post-menarchal female and report that their initial menstrual period occurred \> 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.) * Newly diagnosed with first cancer…
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