CompletedPhase 2

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

United States60 participantsStarted 2002-11

Plain-language 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.

Who can participate

Age range40 Years

SexFEMALE

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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

What they're measuring

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

Timeframe: 6 months

Trial details

NCT IDNCT00429494

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

Results submitted2013-05-20

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