Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy

• Status: Withdrawn
• Trial end date: 2010-07-22
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Criteria

• INCLUSION CRITERIA:

All reproductive age women menarche - age 21, undergoing chemotherapy with agents known to affect ovarian function that have a follicle stimulating hormone level (FSH) less than 20 mIU/L will be offered enrollment. We define premature ovarian failure as the development before age 40 years of greater than 4 months of amenorrhea or menstrual irregularity, associated with two serum FSH levels in the menopausal range (sampled at least 1 mo apart).

EXCLUSION CRITERIA:

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