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Trial record 23 of 289 for:    amenorrhea

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Amenorrhea
Premature Ovarian Failure
Ovarian Function Insufficiency
Interventions Drug: Leuprolide Acetate
Behavioral: Questionnaire
Procedure: Hematopoietic Stem Cell Transplantation
Enrollment 60
Recruitment Details Recruitment period: November 18, 2002 to November 21, 2008. All participants were recruited in medical clinics.
Pre-assignment Details Of the 60 participants enrolled, one participant was excluded prior to treatment due to ineligibility.
Arm/Group Title Leuprolide Acetate
Hide Arm/Group Description Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
Period Title: Overall Study
Started 59
Completed 44
Not Completed 15
Reason Not Completed
Withdrawal by Subject             9
Death             6
Arm/Group Title Leuprolide Acetate
Hide Arm/Group Description Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 59 participants
25
(17 to 39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
59
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants
59
1.Primary Outcome
Title Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 59 patients who underwent HSCT, nine patients refused the second dose of leuprolide and were subsequently taken off study. Six patients died of either disease progression or transplantation-related complications before their ovarian function status was evaluated.
Arm/Group Title Leuprolide Acetate
Hide Arm/Group Description:
Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: participants
37
Time Frame 5 years and 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leuprolide Acetate
Hide Arm/Group Description Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
All-Cause Mortality
Leuprolide Acetate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Leuprolide Acetate
Affected / at Risk (%)
Total   0/59 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Leuprolide Acetate
Affected / at Risk (%)
Total   9/59 (15.25%) 
Reproductive system and breast disorders   
Menopausal side effects  1 [1]  9/59 (15.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
[1]
Menopausal side effects, including hot flushing, vaginal dryness, and mood swings
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Naoto T. Ueno, MD, PhD / Professor
Organization: The University of Texas (UT) MD Anderson Cancer Center
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429494     History of Changes
Other Study ID Numbers: ID01-710
First Submitted: January 29, 2007
First Posted: January 31, 2007
Results First Submitted: May 20, 2013
Results First Posted: July 9, 2013
Last Update Posted: July 9, 2013