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NCT00507780
Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy
Phase 4 trial testing GnRH antagonist in Ovarian Function. Withdrawn.
22 July 2010
Quick facts
| Lead sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | prevention |
| Start date | 18 July 2007 |
| Primary completion | 22 July 2010 |
| Estimated completion | 22 July 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- GnRH antagonist — full drug profile →
Conditions studied
- Ovarian Function — all drugs for Ovarian Function →
- Preservation of Ovarian Function — all drugs for Preservation of Ovarian Function →
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Who can join
Adults 10 to 21, female only, with Ovarian Function or Preservation of Ovarian Function. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will examine whether the drug cetrorelex acetate (Cetrotide\[Registed Trademark\]) can protect ovarian function in women undergoing chemotherapy. Some cancer treatments are known to cause a change in women's periods or to cause menstruation to stop completely, so that they cannot become pregnant. Cetrorelex acetate has been used for many years to lower hormone levels and stop periods in patients undergoing in vitro fertilization treatments. This study will see if making the ovaries inactive may protect them from being affected by certain cancer drugs, and thus preserve fertility. Women up to age 21who have begun menstruating, who have their uterus and at least one functioning ovary, and who are undergoing chemotherapy with cyclophosphamide, busulfan, nitrogen mustard or L-phenalanin mustard may be eligible for this study. Participants undergo the following procedures during this 24-month study: Baseline evaluation * Medical history, physical examination and blood and urine tests * Questionnaire about quality of life, menstrual periods, vaginal bleeding and desire for future fertility * 3D ultrasound of abdomen * DEXA scan to evaluate bone density Assignment to treatment with: * Lo ovral (contraceptive pill to prevent pregnancy and control menstrual periods) alone, or * Lo ovral and the study drug cetrorelex acetate, given as an injection under the skin once a day for six menstrual cycles Evaluations * Transvaginal 3D ultrasound to monitor changes in the ovary - after 6 months of cetrorelex acetate injections * DEXA scan - after 6 months of cetrorelex acetate injections * Blood tests for safety monitoring, pregnancy testing, endocrine tests and research uses - every 3 months during first year, every 6 months during second year * Questionnaire to monitor changes and quality of life - every 3 months during first year, every 6 months during second year.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00507780
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of GnRH antagonist
Trials testing the same drug.
- NCT05326087 — Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT · Phase 3 · not yet recruiting
- NCT07212712 — The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans · NA · not yet recruiting
- NCT06396390 — Comparison of Progestin Primed Ovarian Stimulation (PPOS) vs.GnRH Antagonist Methods on IVF Outcomes · Phase 4 · not yet recruiting
- NCT05759871 — Ovarian Stimulation With FSH Alone Versus FSH Plus GnRH Antagonist in an Oocyte Donor/Recipient Programme · Phase 1, PHASE2 · unknown
- NCT05447208 — Effect of GH on the Blastocyst Euploid Rate in AMA Patients · Phase 3 · recruiting
Other Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) trials
Trials by the same sponsor.
- NCT07502586 — Turner Syndrome: Genetic Considerations · recruiting
- NCT07357701 — Identifying Genome Variants in Non-Obstructive Azoospermia (NOA) or Primary Ovarian Insufficiency (POI) · recruiting
- NCT06851754 — Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency · Phase 3 · recruiting
- NCT05548881 — Implications of Maternal 45,X Mosaicism as a Secondary Genomic Finding Following Cell-Free DNA Sequencing During Pregnan · withdrawn
- NCT06749366 — Uncovering Genes Behind Cartilage Tumors and Vascular Anomalies Using Genomic Sequencing · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00507780 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Last refreshed: 2 July 2017
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