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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00429494 (opens ClinicalTrials.gov in a new tab)Other idID01-710
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
60 participants (actual)
Sponsor
M.D. Anderson Cancer Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Nov 2002
Primary completion
Jun 2011
Completion
Jun 2011
First posted
31 Jan 2007 (estimated)
Last update posted
9 Jul 2013 (estimated)
Conditions
Amenorrhea · Premature Ovarian Failure · Ovarian Function Insufficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200220042006200820102012
  1. Ph 2

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

    NCT00429494

    Nov 2002 to Jun 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Leuprolide AcetateDrug
  • QuestionnaireBehavioral
  • Hematopoietic Stem Cell TransplantationProcedure

Arms1

  • Experimental

    Leuprolide Acetate

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide

    Time frame · 6 months

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 months

Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide

GroupValue (participants)
Leuprolide Acetate37

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Leuprolide AcetateLeuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.–0 / 599 / 59

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2012

3 results

Phase II study of gonadotropin-releasing hormone analog for ovarian function preservation in hematopoietic stem cell transplantation patients.

Cheng et al. 2012The oncologistcited by 23

PMID 22282904PMC3286172DOI 10.1634/theoncologist.2011-0205PUB-22282904

Rights unknown3 results
Source linkSee results (3)

Eligibility

Who could join, as posted.

Sex
Female
Age
up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Hematopoietic stem cell transplantation candidate. * Post-menarche female less than 40 years old. * Premenopausal before the start of transplantation, or the start of oral contraceptive pills. * Follicle-stimulating hormone (FSH) less than or equal to 20 IU/L and Luteinizing hormone (LH) less than or equal to 20 IU/L within 1 weeks of initiation of injection or the ovarian status is determined by Gynecology Oncology Service. * Agree to stop any oral contraceptive pills for a period of 3-6 months starting 1 year post-transplant Exclusion Criteria: * Breast cancer * Ovarian cancer * Pregnancy * Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs

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