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Trial record 23 of 268 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: November 18, 2002 to November 21, 2008. All participants were recruited in medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 60 participants enrolled, one participant was excluded prior to treatment due to ineligibility.

Reporting Groups
  Description
Leuprolide Acetate Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.

Participant Flow:   Overall Study
    Leuprolide Acetate
STARTED   59 
COMPLETED   44 
NOT COMPLETED   15 
Withdrawal by Subject                9 
Death                6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Baseline Measures
   Leuprolide Acetate 
Overall Participants Analyzed 
[Units: Participants]
 59 
Age 
[Units: Years]
Median (Full Range)
 25 
 (17 to 39) 
Gender 
[Units: Participants]
 
Female   59 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   59 


  Outcome Measures

1.  Primary:   Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: CR_Study_Registration@mdanderson.org


Publications of Results:

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