A Phase 2 interventional study of Leuprolide Acetate and Questionnaire in Amenorrhea, Premature Ovarian Failure and Ovarian Function Insufficiency, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to female participants aged Up to 40 Years. Per ClinicalTrials.gov, last updated 2013-07-09.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
Primary Objectives:
All participants in this study will be scheduled for hematopoietic stem cell transplantation at The University of Texas (UT) MD Anderson Cancer Center.
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 are eligible will receive the first dose of leuprolide as an injection into either the shoulder muscle or the thigh muscle during their first clinic visit. 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. Three months after the first dose of injection participants will have another clinic visit where blood tests for ovarian function will be performed. A second dose of the leuprolide will be given as an injection into the muscle at this visit. Again, if patients have low platelet count at that time, platelet transfusion will be given to patients before the injection. Participants will be given a checklist sheet for them to record any side effects while on the effect of leuprolide.
Three months after the last dose of the injection, patients will have the option to start taking or to resume oral contraceptive pills. Those who choose not to take or to resume oral contraceptive pills will be followed and observed for the return of menstrual or monthly cycles. Those who choose to take or to resume oral contraceptive pills, has to stop taking oral contraceptive pills for a period of 3-6 months starting 1 year after transplantation for us to assess the ovarian function.
During the period of follow up and observation of the return of menstruation, participants will be seen every two months either in the clinic or in the hospital if they are admitted. Participants will fill out questionnaires about their menstrual history at these visits. They should take about 15 minutes to complete. Blood tests for the ovarian function will also be done during these visits.
This is an investigational study. The drug used in this study is commercially available and has been approved by FDA for use in prostate cancer patients. Its use in this study is investigational. About seventy-five patients will take part in this study. All will be enrolled at MD Anderson.
172 studies on the registry are indexed under Primary Ovarian Insufficiency; 45 are open to participants now.
This study's enrollment of 60 is above the median of 49 across 109 interventional studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
Drug: Leuprolide Acetate · Behavioral: Questionnaire · Procedure: Hematopoietic Stem Cell Transplantation
22.5 mg IM injection 2 months before transplant and 3 months post-transplant.
Also known as: Leuprolide Acetate (delayed release), Lupron Depot
Questionnaires taking about 15 minutes to complete.
Also known as: Survey
Stem cell infusion on Day 0.
Also known as: HSCT, Stem Cell Transplant
Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide
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.
Time frame: 6 months
Recruitment period: November 18, 2002 to November 21, 2008. All participants were recruited in medical clinics.
| Milestone | Leuprolide Acetate |
|---|---|
| Started | 59 |
| Completed | 44 |
| Not completed | 15 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Death | 6 |
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.
| participants | Leuprolide Acetate |
|---|---|
| Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide | 37 |
Collected over 5 years and 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Leuprolide Acetate | — | 0/59 (0%) | 9/59 (15.3%) |
| Event | Leuprolide Acetate |
|---|---|
| Menopausal side effectsReproductive system and breast disorders | 9/59 |
| Age Continuous(years) | Leuprolide Acetate |
|---|---|
| Median | 25 (17 to 39) |
| Sex: Female, Male(Participants) | Leuprolide Acetate |
|---|---|
| Female | 59 |
| Male | 0 |
| Region of Enrollment(participants) | Leuprolide Acetate |
|---|---|
| United States | 59 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Primary Ovarian Insufficiency→
M.D. Anderson Cancer Center