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

This study has been completed.

Sponsor:

Collaborator:

TAP Pharmaceutical Products Inc.

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT00429494

First received: January 29, 2007

Last updated: February 15, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 29, 2007

Last Updated Date

February 15, 2013

Start Date ^ICMJE

November 2002

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of patients with secondary amenorrhea following 3-month depot leuprolide [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Hormonal profile blood tests including FSH, 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 patients 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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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 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

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

Experimental: Leuprolide Acetate

Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.

Interventions:

Drug: Leuprolide Acetate
Behavioral: Questionnaire
Procedure: Hematopoietic Stem Cell Transplantation

Publications *

Not Provided

* 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

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

November 2008 (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

Gender

Female

Ages

up to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00429494

Other Study ID Numbers ^ICMJE

ID01-710

Has Data Monitoring Committee

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

Information Provided By

M.D. Anderson Cancer Center

Verification Date

February 2013

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

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