Phase 2 Completed N=59 Treatment

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

Amenorrhea · premature ovarian failure · Ovarian Function Insufficiency

Source: ClinicalTrials.gov NCT00429494 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcomePrimary: Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide — 37 participants

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.

Outcome Measures

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

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. Informational only — not medical advice.