Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
NCT06513962 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-05
Summary
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 an 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.
Conditions
- Hematopoietic and Lymphatic System Neoplasm
- Malignant Solid Neoplasm
Interventions
- OTHER
-
Best Practice
Receive standard chemotherapy
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- OTHER
-
Electronic Health Record Review
Ancillary studies
- OTHER
-
Survey Administration
Ancillary studies
- DRUG
-
Triptorelin Pamoate
Given IM
Sponsors & Collaborators
-
Children's Oncology Group
lead NETWORK
Principal Investigators
-
Eric J Chow · Children's Oncology Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 39 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-27
- Primary Completion
- 2029-10-30
- Completion
- 2029-10-30
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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