Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy

Withdrawn before enrolling · Phase 4

Conditions studied: Ovarian Function, Preservation of Ovarian Function

In brief

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.

Key facts

Study ID

NCT00507780

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

0

Starts

2007-07-18

Expected to finish

2010-07-22

Last updated by the study team

2017-07-02

Who can join

Age: 10 and older, up to 21. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• FSH greater than 20 mIU/L
• Sensitivity or allergy to oral contraceptives (lo ovral) or cetrorelix acetate
• Patients who have had surgical removal of their ovaries
• Patients who are currently pregnant or attempting conception
• Severe renal impairment
• Premenarchal patients
• Patients greater than 21
• Patients who have undergone radiation therapy or who are scheduled to undergo radiation therapy during the study period.
• Patients with a family history of premature ovarian failure

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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