MedTrace Logo

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

NCT00429494 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-07-09

Study results available
· View outcomes & findings →

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.

Conditions

  • Amenorrhea
  • Premature Ovarian Failure
  • Ovarian Function Insufficiency

Interventions

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.

Sponsors & Collaborators

  • TAP Pharmaceutical Products Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Naoto Ueno, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00429494 on ClinicalTrials.gov