Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
Study NCT ID:
NCT00429494
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
2007-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: