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| 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:
| 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 |
| 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:
Behavioral: Questionnaire
Questionnaires taking about 15 minutes to complete.
Other Name: Survey
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Naoto Ueno, MD, PhD | M.D. Anderson Cancer Center |
More Information
| 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 |
|
Hematopoietic Stem Cell Transplantation GnRH Analogue Ovarian Function Fertility |
Leuprolide Acetate Lupron Depot Questionnaire Survey |
|
Leuprolide Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |