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

Completed · Phase 2

Conditions studied: Amenorrhea, Premature Ovarian Failure, Ovarian Function Insufficiency

In brief

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.

Key facts

Study ID

NCT00429494

Run by

M.D. Anderson Cancer Center

People needed

60

Starts

2002-11-01

Expected to finish

2011-06-01

Last updated by the study team

2013-07-09

Who can join

Age: any, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Breast cancer
• Ovarian cancer
• Pregnancy
• Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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