Official Title: “Phase II Study of GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients”

Primary Objectives:

1. To determine the effectiveness of the 3-month depot leuprolide in inducing and maintaining secondary amenorrhea in patients undergo hematopoietic stem cell transplantation.

2. 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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: November 2008

All participants in this study will be scheduled for hematopoietic stem cell transplantation at UTMDACC.

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 M. D. Anderson.

Intervention(s) in this Clinical Trial

• Drug: Leuprolide Acetate
  • 22.5 mg IM injection 2 months before transplant and 3 months post-transplant.
• Behavioral: Questionnaire
  • Questionnaires taking about 15 minutes to complete.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Leuprolide Acetate

Primary Measures

• The goals of this clinical research study are to save the fertility of the patients who have hematopoietic stem cell transplantation and to prevent them from suffering the side effects of early menopause.
  • Time Frame: 6 Years
    Safety Issue?: No

Secondary Measures

• Researchers also want to see if the study drug, leuprolide, is able to save ovarian function of the patients when they are receiving high dose chemotherapy and/or radiation therapy.
  • Time Frame: 6 Years
    Safety Issue?: No

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.
• FSH less than or equal to 20 IU/L and 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 GnRH analogs

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: M.D. Anderson Cancer Center

Overall Clinical Trial Officials and Contacts

Naoto Ueno, MD, PhD Principal Investigator U.T.M.D. Anderson Cancer Center  

Overall Contact: Naoto Ueno, MD, PhD 713-794-5780 

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00429494

Study ID Number: ID01-710

ClinicalTrials.gov Identifier: NCT00429494

Health Authority: United States: Institutional Review Board