GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: TAP Pharmaceutical Products Inc.
• Treatments: Leuprolide

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