GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amenorrhea; Premature Ovarian Failure; Ovarian Function Insufficiency
Intervention: Leuprolide Acetate (Drug); Questionnaire (Behavioral); Hematopoietic Stem Cell Transplantation (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Naoto Ueno, MD, PhD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Summary
Primary Objectives:
- To determine the effectiveness of the 3-month depot leuprolide in inducing and
maintaining secondary amenorrhea in patients undergo hematopoietic stem cell
transplantation.
- To determine the incidence of regained ovarian function manifested as spontaneous
restoration of menstruation and normalization of hormonal level in patients after
transplantation and discontinuation of long-acting leuprolide.
Clinical Details
Official title: Phase II Study of GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide
Detailed description:
All participants in this study will be scheduled for hematopoietic stem cell transplantation
at The University of Texas (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
leuprolide.
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.
Eligibility
Minimum age: N/A.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Hematopoietic stem cell transplantation candidate.
- Post-menarche female less than 40 years old.
- Premenopausal before the start of transplantation, or the start of oral contraceptive
pills.
- Follicle-stimulating hormone (FSH) less than or equal to 20 IU/L and Luteinizing
hormone (LH) less than or equal to 20 IU/L within 1 weeks of initiation of injection
or the ovarian status is determined by Gynecology Oncology Service.
- Agree to stop any oral contraceptive pills for a period of 3-6 months starting 1 year
post-transplant
Exclusion Criteria:
- Breast cancer
- Ovarian cancer
- Pregnancy
- Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs
Locations and Contacts
UT MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
The University of Texas (UT) MD Anderson Cancer Center official website
Starting date: November 2002
Last updated: May 20, 2013
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