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

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ClinicalTrials.gov Identifier: NCT00429494
Recruitment Status : Completed
First Posted : January 31, 2007
Results First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Sponsor:
Collaborator:
TAP Pharmaceutical Products Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE January 29, 2007
First Posted Date  ICMJE January 31, 2007
Results First Submitted Date  ICMJE May 20, 2013
Results First Posted Date  ICMJE July 9, 2013
Last Update Posted Date July 9, 2013
Study Start Date  ICMJE November 2002
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide [ Time Frame: 6 months ]
Hormonal profile blood tests including follicle-stimulating hormone (FSH) test, luteinizing hormone (LH) and estradiol levels done every two months with menstruation questionnaire, starting three months after the injection of the second dose of leuprolide until the restoration of spontaneous menstruation or the presence of ovarian failure. Any unexpected vaginal bleeding or side effects during the period covered by leuprolide injection, which is 6 months, is recorded by participants in a monitoring checklist sheet given to them.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00429494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Official Title  ICMJE Phase II Study of GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Amenorrhea
  • Premature Ovarian Failure
  • Ovarian Function Insufficiency
Intervention  ICMJE
  • Drug: Leuprolide Acetate
    22.5 mg IM injection 2 months before transplant and 3 months post-transplant.
    Other Names:
    • Leuprolide Acetate (delayed release)
    • Lupron Depot
  • Behavioral: Questionnaire
    Questionnaires taking about 15 minutes to complete.
    Other Name: Survey
  • Procedure: Hematopoietic Stem Cell Transplantation
    Stem cell infusion on Day 0.
    Other Names:
    • HSCT
    • Stem Cell Transplant
Study Arms  ICMJE Experimental: Leuprolide Acetate
Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
Interventions:
  • Drug: Leuprolide Acetate
  • Behavioral: Questionnaire
  • Procedure: Hematopoietic Stem Cell Transplantation
Publications * Cheng YC, Takagi M, Milbourne A, Champlin RE, Ueno NT. Phase II study of gonadotropin-releasing hormone analog for ovarian function preservation in hematopoietic stem cell transplantation patients. Oncologist. 2012;17(2):233-8. doi: 10.1634/theoncologist.2011-0205. Epub 2012 Jan 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2012)
60
Original Enrollment  ICMJE
 (submitted: January 30, 2007)
75
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00429494
Other Study ID Numbers  ICMJE ID01-710
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE TAP Pharmaceutical Products Inc.
Investigators  ICMJE
Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP