Premature Ovarian Failure Clinical Trial
Official title:
Phase II Study of GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Verified date | May 2013 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 40 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | TAP Pharmaceutical Products Inc. |
United States,
Cheng YC, Takagi M, Milbourne A, Champlin RE, Ueno NT. Phase II study of gonadotropin-releasing hormone analog for ovarian function preservation in hematopoietic stem cell transplantation patients. Oncologist. 2012;17(2):233-8. doi: 10.1634/theoncologist. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Unknown status |
NCT01853501 -
Effects of ADSC Therapy in Women With POF
|
Phase 4 | |
Completed |
NCT00417066 -
Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders
|
Phase 4 | |
Active, not recruiting |
NCT04675970 -
Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy
|
||
Recruiting |
NCT03480412 -
Second Step Protocol in Poor Ovarian Responder (POR)
|
||
Completed |
NCT02644447 -
Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF
|
Phase 1/Phase 2 | |
Completed |
NCT03840824 -
Blood Spot Self-administered Test and Assay
|
||
Recruiting |
NCT00119925 -
'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists"
|
N/A | |
Recruiting |
NCT06117982 -
The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency
|
Phase 2 | |
Suspended |
NCT03816852 -
The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency
|
Phase 2 | |
Not yet recruiting |
NCT04390308 -
Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
|
||
Completed |
NCT02783937 -
Filgrastim for Premature Ovarian Insufficiency
|
Phase 4 | |
Completed |
NCT00295087 -
X-Chromosome Inactivation Status and Premature Ovarian Failure
|
N/A | |
Not yet recruiting |
NCT05522634 -
A Clinical Study of Chinese Herbal Compound TJAOA101 in the Treatment of Premature Ovarian Insufficiency
|
Early Phase 1 | |
Recruiting |
NCT05838157 -
The Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age
|
||
Withdrawn |
NCT01129947 -
The Use of DHEA in Women With Premature Ovarian Failure
|
Phase 0 | |
Completed |
NCT00001275 -
Ovarian Follicle Function in Patients With Primary Ovarian Failure
|
N/A | |
Not yet recruiting |
NCT04306185 -
Ovarian Fragmentation Study (Crespo Medical Team)
|
N/A | |
Recruiting |
NCT02062931 -
Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure
|
Phase 1/Phase 2 | |
Completed |
NCT02151890 -
Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure
|
Phase 1/Phase 2 | |
Completed |
NCT02372474 -
"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure
|
Phase 1/Phase 2 |