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

Premature Ovarian Failure Clinical Trial

Official title:

Phase II Study of GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429494
• Other study ID #: ID01-710
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2007
• Last updated: May 20, 2013
• Start date: November 2002
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amenorrhea
• Menopause, Premature
• Ovarian Function Insufficiency
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

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.

Procedure:
• Hematopoietic Stem Cell Transplantation
Stem cell infusion on Day 0.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	TAP Pharmaceutical Products Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide	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.	6 months	No

External Links

•   The University of Texas (UT) MD Anderson Cancer Center official website