Phase II Study of GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
All participants in this study will be scheduled for hematopoietic stem cell transplantation
at UT MD Anderson Cancer Center.
Within two months before the transplantation, all participants will have a medical history,
physical exam, and blood tests for ovarian function and platelet count. Participants will
also need to have a gynecologic exam within one year before the transplantation.
Participants who are eligible will receive the first dose of leuprolide as an injection into
either the shoulder muscle or the thigh muscle during their first clinic visit. Participants
who have low platelet count will be given platelet transfusion before the injection.
Participants will then go on to have the transplantation as scheduled. Three months after
the first dose of injection participants will have another clinic visit where blood tests
for ovarian function will be performed. A second dose of the leuprolide will be given as an
injection into the muscle at this visit. Again, if patients have low platelet count at that
time, platelet transfusion will be given to patients before the injection. Participants will
be given a checklist sheet for them to record any side effects while on the effect of
Three months after the last dose of the injection, patients will have the option to start
taking or to resume oral contraceptive pills. Those who choose not to take or to resume oral
contraceptive pills will be followed and observed for the return of menstrual or monthly
cycles. Those who choose to take or to resume oral contraceptive pills, has to stop taking
oral contraceptive pills for a period of 3-6 months starting 1 year after transplantation
for us to assess the ovarian function.
During the period of follow up and observation of the return of menstruation, participants
will be seen every two months either in the clinic or in the hospital if they are admitted.
Participants will fill out questionnaires about their menstrual history at these visits.
They should take about 15 minutes to complete. Blood tests for the ovarian function will
also be done during these visits.
This is an investigational study. The drug used in this study is commercially available and
has been approved by FDA for use in prostate cancer patients. Its use in this study is
investigational. About seventy-five patients will take part in this study. All will be
enrolled at MD Anderson.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with secondary amenorrhea following 3-month depot leuprolide
Hormonal profile blood tests including FSH, LH and estradiol levels done every two months with menstruation questionnaire, starting three months after the injection of the second dose of leuprolide until the restoration of spontaneous menstruation or the presence of ovarian failure. Any unexpected vaginal bleeding or side effects during the period covered by leuprolide injection, which is 6 months, is recorded by patients in a monitoring checklist sheet given to them.
Naoto Ueno, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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