Status:
COMPLETED
GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
TAP Pharmaceutical Products Inc.
Conditions:
Amenorrhea
Premature Ovarian Failure
Eligibility:
FEMALE
Up to 40 years
Phase:
PHASE2
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...
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, a...
Eligibility Criteria
Inclusion
- 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
- Breast cancer
- Ovarian cancer
- Pregnancy
- Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00429494
Start Date
November 1 2002
End Date
June 1 2011
Last Update
July 9 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030