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 range

40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Amenorrhea trials