Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy
Public ClinicalTrials.gov record NCT00507780. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Use of the GnRH Agonist Leuprolide Acetate (Lupron(Registered Trademark)) to Preserve Ovarian Function in Women Undergoing Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00507780
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- NIH
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 21 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 17, 2007
- Primary completion
- Jul 21, 2010
- Completion
- Jul 21, 2010
- Last update posted
- Jul 1, 2017
2007 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00507780, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00507780 live on ClinicalTrials.gov.