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NCT00429494 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Amenorrhea and Premature Ovarian Failure, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT00429494: Completed Phase 2 study of Amenorrhea and Premature Ovarian Failure, sponsored by M.D. Anderson Cancer Center.

NCT00429494 is a Phase 2 study of Amenorrhea and Premature Ovarian Failure that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants, below the 353-participant average among 6 other Amenorrhea trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00429494, a Phase 2 study of Amenorrhea and Premature Ovarian Failure, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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 monitor

Interventions

  • DRUG Leuprolide Acetate
  • BEHAVIORAL Questionnaire
  • PROCEDURE Hematopoietic Stem Cell Transplantation

Study Locations (1)

Texas

  • UT MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2002-11
Est. Completion 2011-06
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00429494 record still lists

NCT00429494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 353-participant average among 6 other Amenorrhea trials with a reported enrollment target (83% lower).

The record links to 3 conditions, with Amenorrhea appearing as the primary indexed condition, and to 3 interventions - of which Leuprolide Acetate is the first listed.

NCT00429494 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT00429494 about?

NCT00429494 is a clinical study titled "GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients". 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 menst...

What is the current status of trial NCT00429494?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2002-11. Estimated completion is 2011-06.

What conditions does trial NCT00429494 study?

This clinical trial studies the following conditions: Amenorrhea, Premature Ovarian Failure, Ovarian Function Insufficiency.

What interventions are being tested in trial NCT00429494?

The interventions under investigation include: Leuprolide Acetate (DRUG), Questionnaire (BEHAVIORAL), Hematopoietic Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT00429494?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00429494 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00429494, the US trial registry maintained by the National Library of Medicine. NCT00429494 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.