Trial Outcomes & Findings for GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients (NCT NCT00429494)
NCT ID: NCT00429494
Last Updated: 2013-07-09
Results Overview
Hormonal profile blood tests including follicle-stimulating hormone (FSH) test, luteinizing hormone (LH) and estradiol levels done every two months with menstruation questionnaire, starting three months after the injection of the second dose of leuprolide until the restoration of spontaneous menstruation or the presence of ovarian failure. Any unexpected vaginal bleeding or side effects during the period covered by leuprolide injection, which is 6 months, is recorded by participants in a monitoring checklist sheet given to them.
COMPLETED
PHASE2
60 participants
6 months
2013-07-09
Participant Flow
Recruitment period: November 18, 2002 to November 21, 2008. All participants were recruited in medical clinics.
Of the 60 participants enrolled, one participant was excluded prior to treatment due to ineligibility.
Participant milestones
| Measure |
Leuprolide Acetate
Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Leuprolide Acetate
Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Death
|
6
|
Baseline Characteristics
GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Baseline characteristics by cohort
| Measure |
Leuprolide Acetate
n=59 Participants
Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
|
|---|---|
|
Age Continuous
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Of the 59 patients who underwent HSCT, nine patients refused the second dose of leuprolide and were subsequently taken off study. Six patients died of either disease progression or transplantation-related complications before their ovarian function status was evaluated.
Hormonal profile blood tests including follicle-stimulating hormone (FSH) test, luteinizing hormone (LH) and estradiol levels done every two months with menstruation questionnaire, starting three months after the injection of the second dose of leuprolide until the restoration of spontaneous menstruation or the presence of ovarian failure. Any unexpected vaginal bleeding or side effects during the period covered by leuprolide injection, which is 6 months, is recorded by participants in a monitoring checklist sheet given to them.
Outcome measures
| Measure |
Leuprolide Acetate
n=44 Participants
Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
|
|---|---|
|
Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide
|
37 participants
|
Adverse Events
Leuprolide Acetate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Leuprolide Acetate
n=59 participants at risk
Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
|
|---|---|
|
Reproductive system and breast disorders
Menopausal side effects
|
15.3%
9/59 • 5 years and 6 months
|
Additional Information
Dr. Naoto T. Ueno, MD, PhD / Professor
The University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place