MedTrace Logo

Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy

NCT00507780 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-07-02

No results posted yet for this study

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.

Conditions

  • Ovarian Function
  • Preservation of Ovarian Function

Interventions

DRUG

GnRH antagonist

Sponsors & Collaborators

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

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-18
Primary Completion
2010-07-22
Completion
2010-07-22

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00507780 on ClinicalTrials.gov