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Preservation of Ovarian Function After Hematopoietic Cell Transplant
Plain-language guide to NCT01343368: phase 2 non-randomized trial of Leuprolide, 19 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01343368
- Phase
- phase 2
- Status
- terminated early
- Start
- 2011-07
- Completion (planned or actual)
- 2015-04
- Participants
- 19 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), supportive_care
- Conditions studied
- Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease; Acute Myeloid Leukemia; Myeloproliferative Disorders
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Leuprolide.
Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide.
It had two arms (groups): Interventional - Received Leuprolide (experimental) and Observational Arm (active comparator).
The registry classes the interventions as biological and drug.
More on the Plan
The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure.
Who Took Part
19 actual participants took part.
It was open to women only aged from 50 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Eligible for myeloablative allogenic or autologous hematopoietic cell transplant (HCT). Post-menarchal female \< or = 50 years of age. Normal antimullerian hormone (AMH) level and/or follicle stimulating hormone (FSH)/leuprolide (LH) levels for age/stage of puberty. Post-menarchal female ≤ 50 years of age. Normal AMH level and/or FSH/LH for age/stage of puberty.
The full record lists 10 inclusion and 4 exclusion criteria; among the exclusions: all arms:; surgical resection of one or both ovaries. prior hysterectomy is allowed as long as the ovaries are intact.
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
The Leuprolide group and the comparison group ran side by side rather than switching.
Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2011-07 with completion listed for 2015-04.
It ran at 1 site in United States.
Its stated primary purpose is supportive care.
What Was Measured
The main thing measured (primary outcome): Comparison of Number of Patients With Ovarian Failure (time frame: Through Day 180 Post Transplant).
It also tracked 14 secondary outcomes, for example Comparison of Number of Patients Who Stopped Menstrual Bleeding, Comparison of Follicle Stimulating Hormone (FSH) Levels, Comparison of Follicle Stimulating Hormone (FSH) Levels, Comparison of Follicle Stimulating Hormone (FSH) Levels, Comparison of Follicle Stimulating Hormone (FSH) Levels and Comparison of Follicle Stimulating Hormone (FSH) Levels.
What This Means in Plain Language
Put simply, this is a phase 2, non-randomized trial of Leuprolide in 19 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); 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.