COMPARISON OF A NEW FORMULATION OF GOSERELIN (Pepti 3.6 mg) to Zoladex® 3.6 mg IN PATIENTS WITH DYSFUNCTIONAL UTERINE BLEEDING REQUIRING ENDOMETRIAL ABLATION.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Non-inferiority in terms of activity of test drug versus comparator
研究概览
简要总结
The comparator drug (Zoladex 3.6 mg) is approved for use as a thinning agent for the endometrium prior to endometrial ablation. The dosing recommendation is one or two depots with each depot given four weeks apart. When two depots are administered, surgery should be performed within two to four weeks following administration of the second depot.
详细描述
The primary objective of the study is to demonstrate non-inferiority of a generic formulation of goserelin 3.6 mg as compared to Zoladex ® 3.6 mg on endometrial thinning prior to surgery. The study is an open label, multicenter, prospective, parallel group randomized study.
Blind for Sponsor, ultrasound assessment, testing labs and statistician, the study will be performed in premenopausal women with dysfunctional uterine bleeding (DUB) eligible for endometrial ablation. Patients will be randomized in a 1 to 1 ratio to receive either the Peptigroupe test product (Pepti 3.6 mg) or Zoladex® 3.6 mg for a treatment of 8 weeks (two injections).
Ultrasonic measurement of endometrial thickness will be performed on screening and on days 0 (pre-injection), 28 (pre-injection) and 42 (pre surgical procedure).
The pharmacodynamics profile will be tabulated at the end of the study on the basis of the following data:
- Estradiol
- LH and FSH as additional information on hormone response
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Sponsor, independant statistician, radiologists and bioanalytical lab are all blinded to treatment regimen
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be pre-Menopausal females with regular menstrual cycles and > 30 years of age
- •Premenopausal at enrollment as determined by FSH measurement ≤ 60 IU/mL.
- •Endometrial thickness at pre-treatment less than 20 mm.
- •Diagnosis of Dysfunctional Uterine Bleeding and requiring endometrial ablation
- •Tumour negative cytology and histology
- •Appropriate sized uterus with no anatomic pathologies
- •Patient is not pregnant and does not wish to become pregnant in the future
- •Patient is willing to use a non-hormonal contraception method during the study, nor an intra-uterine device
- •Patient has no endocrine disorders, is not receiving hormonal therapies or non-steroidal anti-inflammatory medication. (prophylactic antibiotics can be administered according to the usual practice of the investigator)
- •Have the ability to understand the requirements of the study and is willing to provide written informed consent
- •Agree to abide by the study restrictions and return for the required assessments
- •Only patients which can be discontinued safely from contra-indicated medications discussed below in section 7.4 can be included in the study.
排除标准
- •Be pregnant or have desire to conceive
- •Have abnormal endometrial cytology as confirmed by histology
- •Have active endometritis
- •Have active pelvic inflammatory disease
- •Have active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Patient may be considered for study enrollment.
- •Presence of bacteremia, sepsis, or other active systemic infection
- •Have active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of inclusion
- •Known/suspected gynecological malignancy within the past 5 years
- •Known clotting defects or bleeding disorders
- •Untreated/unevaluated cervical dysplasia
- •Known/suspected abdominal/pelvic cancer
- •Atypical Hyperplasia
- •Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section
- •Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
- •Currently on anticoagulants
- •Have a known hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonists, any LHRH agonists (e.g., leuprolide (Lupron®), goserelin ( Zoladex®) etc.) or to the PLGA polymers contained in the study formulation
- •Have a severe liver disease (e.g., cirrhosis, chronic active hepatitis or chronic persistent hepatitis) or has persistent ALT, AST ˃ 2 X ULN, serum creatinine ˃ 2 X ULN, serum bilirubin ˃ 2 X ULN
- •Have received an investigational drug or participated in a clinical trial within the last 30 days
- •Have clinically serious and/or unstable concurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
- •Patients with BMI ˂ 18
- •Anticoagulated patients with INR ≥ 2
- •Patients with a history of QT prolongation, congenital long QT syndrome, electrolyte abnormalities, CHF, or concurrent administration with QT prolonging drugs or QTc ˃450 msec.
研究组 & 干预措施
Pepti 3.6 treatment
Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28
干预措施: Pepti 3.6 mg (Drug)
Zoladex 3.6 mg treatment
Patients treated with goserelin depot 3.6 mg. One injection on Day 0 and a second injection on Day 28
干预措施: Pepti 3.6 mg (Drug)
结局指标
主要结局
Non-inferiority in terms of activity of test drug versus comparator
时间窗: 1 year
Non-inferiority of test drug compared to comparator in terms of reduction of the endometrial thickness prior to surgical ablation
次要结局
未报告次要终点