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Phase 2 N=59 Treatment

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

Amenorrhea · Premature Ovarian Failure · Ovarian Function Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT00429494 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide — 37 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Leuprolide Acetate (Drug); Questionnaire (Behavioral); Hematopoietic Stem Cell Transplantation (Procedure)
Age
Pediatric, Adult
Sex
Female
Sponsor
M.D. Anderson Cancer Center
Primary completion
Jun 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide		 37 —

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00429494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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