GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit
研究概览
简要总结
The purpose of this study it to determine whether the use of a gonadotropin releasing hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with rheumatic diseases will provide greater ovarian protection than placebo.
详细描述
Patients will be women ages 18-40 with either a severe rheumatic disease requiring cyclophosphamide or interstitial lung disease requiring cyclophosphamide to be administered either daily orally; monthly intravenously; or intravenously every 2 weeks for 6 doses. Because cyclophosphamide treatment may be required urgently for some indications, study entry may occur before either the first or second dose of cyclophosphamide for patients receiving cyclophosphamide intravenously.
Of 16 participants who were screened, only 14 were randomized and only 7 participants actually completed the study. Due to this low number, follicle stimulating hormone (FSH) levels were not obtained.
Secondary outcome measures that are not available include presence of menses and FSH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Symptoms consistent with ovarian failure based on gynecologic evaluation and confirmatory laboratory testing
- •Prior unilateral or bilateral oophorectomy
- •Cervical intraepithelial neoplasia (CIN 2, or more severe), that has not been adequately evaluated or is not being adequately treated
- •Contraindications to use of GnRH-a (e.g., undiagnosed abnormal uterine bleeding)
- •Prior adverse or allergic reaction to GnRH-a
- •A history of severe psychiatric disorders, particularly severe depression that is currently not adequately treated
- •History of significant noncompliance with medical treatment
- •Patients with major risk factors for decreased bone mineral content such as chronic alcohol and/or tobacco use, strong family history of osteoporosis, or chronic use of drugs that can reduce bone mass such as anticonvulsants that have not already been addressed with appropriate measures to preserve bone mass.
- •Pregnant or breastfeeding
- •Significant thrombotic event requiring treatment that will not have received appropriate therapy for at least 4 weeks before initiation of study drug.
研究组 & 干预措施
LUPRON
Monthly depot leuprolide acetate 3.75 mg injection during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
干预措施: depot leuprolide acetate 3.75 mg (Drug)
Placebo
Monthly placebo injection during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses.
干预措施: Placebo (Drug)
结局指标
主要结局
Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit
时间窗: Day 0 to 6-month post-intervention visit
AMH was quantified in vitro a commercially available enzyme linked immunosorbent assay (ELISA) (Beckman Coulter; Marseille, France) was used for in vitro quantitative measurement of serum AMH.
次要结局
- Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,(baseline and 6 months)
- Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4.(baseline and 6 months)
- Mean Antral Follicle Count (AFC)(baseline and 6 months)
- Mean Ovarian Volume.(baseline and 6 months)
研究者
Joseph Mccune
Michael H. and Marcia S. Klein Professor of Rheumatic Diseases and Director, Lupus Clinic
University of Michigan