CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Leuprolide Acetate +2 moredrug
Likely dose
Leuprolide Acetate 22.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00429494
NCT00429494Phase 2Completed
CompareCT.gov

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

M.D. Anderson Cancer Center·interventional·Posted Jan 31, 2007·Updated Jul 9, 2013

In Brief

A Phase 2 clinical trial evaluating Leuprolide Acetate, Questionnaire, and 1 other intervention for Amenorrhea and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmenorrhea, Premature Ovarian Failure, Ovarian Function Insufficiency
CountriesUnited States
CollaboratorsTAP Pharmaceutical Products Inc.

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2007
Enrollment StartNov 1, 2002
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 19.4 years ago

Interventions

Leuprolide Acetatedrug

22.5 mg IM injection 2 months before transplant and 3 months post-transplant.

Questionnairebehavioral

Questionnaires taking about 15 minutes to complete.

Hematopoietic Stem Cell Transplantationprocedure

Stem cell infusion on Day 0.