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临床试验/NCT00429494
NCT00429494已完成2 期

Phase II Study of GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2002年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Breast cancer
  • Ovarian cancer
  • Pregnancy
  • Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs

研究组 & 干预措施

Leuprolide Acetate

Experimental

Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.

干预措施: Leuprolide Acetate (Drug)

Leuprolide Acetate

Experimental

Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.

干预措施: Questionnaire (Behavioral)

Leuprolide Acetate

Experimental

Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.

干预措施: Hematopoietic Stem Cell Transplantation (Procedure)

结局指标

主要结局

Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide

时间窗: 6 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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