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GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Plain-language guide to NCT00429494: phase 2 interventional trial of Leuprolide, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00429494
- Phase
- phase 2
- Status
- completed
- Start
- 2002-11
- Completion (planned or actual)
- 2011-06
- Participants
- 60 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Amenorrhea; Premature Ovarian Failure; Ovarian Function Insufficiency
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Leuprolide.
It had 1 arm (groups): Leuprolide Acetate (experimental).
The registry classes the interventions as behavioral, drug and procedure.
More on the Plan
Within two months before the transplantation, all participants will have a medical history, physical exam, and blood tests for ovarian function and platelet count.
Participants will also need to have a gynecologic exam within one year before the transplantation.
Participants who have low platelet count will be given platelet transfusion before the injection.
Participants will then go on to have the transplantation as scheduled.
Who Took Part
The registry lists 60 actual participants took part.
It was open to women only aged up to 40 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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. Agree to stop any oral contraceptive pills for a period of 3-6 months starting 1 year post-transplant.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: hypersensitivity to any gonadotropin-releasing hormone (gnrh) analogs.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2002-11 with completion listed for 2011-06.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide (time frame: 6 months).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Leuprolide in 60 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Leuprolide compound page, all human trials.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.