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GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
This study is ongoing, but not recruiting participants.

First Received on January 29, 2007.   Last Updated on April 13, 2011   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: TAP Pharmaceutical Products Inc.
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429494
  Purpose

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.

Condition Intervention Phase
Hematopoietic Stem Cell Transplantation
Drug: Leuprolide Acetate
Behavioral: Questionnaire
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of patients with secondary amenorrhea following 3-month depot leuprolide [ Time Frame: Baseline, with each dose (3 months), then every 2 months following second dose. ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: November 2002
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Leuprolide Acetate + Questionnaire 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429494

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
TAP Pharmaceutical Products Inc.
Investigators
Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Naoto Ueno, MD, PhD/Associate Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429494     History of Changes
Other Study ID Numbers: ID01-710
Study First Received: January 29, 2007
Last Updated: April 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Hematopoietic Stem Cell Transplantation
GnRH Analogue
Ovarian Function
Fertility
Leuprolide Acetate
Lupron Depot
Questionnaire
Survey

Additional relevant MeSH terms:
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012