EUCTR2007-006474-28-PL进行中（未招募）不适用
A Phase II, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects with Endometriosis
eurocrine Biosciences, INC0 个研究点目标入组 180 人开始时间: 2008年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •To participate in this study, subjects must:
- •Be female, aged 18 to 45 years, inclusive.
- •Have a total Composite Pelvic Signs and Symptoms Score (CPSSS)
- •of =6 at screening.
- •Have a score of at least 2 for the dysmenorrhea CPSSS component and at least 1
- •for the nonmenstrual pelvic pain CPSSS component at baseline (Day 1, Week 1).
- •Be at 2 to 5 days (inclusive) after the onset of menses prior to randomization
- •Have had a diagnosis of endometriosis made following laparoscopic visualization of
- •the disease within 5 years of the start of screening with recurrent or persistent
- •Have documented negative mammogram results within 12 months of screening if
- •over the age of 40 years.
- •Have a history of regular spontaneous menstrual cycles. Assessment of cycle
- •duration should be based on observations in the absence of drugs or conditions that
- •are known to affect the cycle (e.g., oral contraceptives, leuprorelin, pregnancy)
- •Have a spontaneous menstrual cycle of 28 days (±5 days) prior to randomization.
- •Have a Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive.
- •Agree to use two forms of nonhormonal contraception (e.g. condom and spermicide)
- •during the study (from the signing of the consent until the final study visit [end of
- •Week 30 or early termination]).
- •Have a negative urine pregnancy test at screening and prior to dosing (at baseline)
- •at the beginning of Week 1.
- •Have a minimum of 7 days of e-Diary data entries prior to randomization.
- •Be willing to comply with all study procedures and restrictions.
- •Be able to read and understand the Patient Information Sheet (PIS), and sign the
- •consent before entering into the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from the study if they:
- •Were administered a GnRH agonist, GnRH antagonist, danazol, or have received
- •any of these agents within 6 months of the start of screening.
- •Were administered subcutaneous medroxyprogesterone acetate (DMPA-SC) or i.m.
- •medroxyprogesterone acetate (DMPA-IM), or have received either of these agents
- •within 3 months of the start of screening.
- •Have been nonresponsive to GnRH agonist or antagonist therapy for the
- •management of endometriosis.
- •Are currently using hormonal contraception (for endometriosis or contraception) or
- •other forms of hormonal therapy for endometriosis or have received such therapy
- •within 1 month of the start of screening.
- •Have had diagnostic laparoscopy or surgical intervention for endometriosis within
- •1 month of the start of screening.
- •Have had a hysterectomy or oopherectomy.
- •Have had prior treatment with NBI-56418.
- •Have uterine fibroids =3 cm in diameter as determined by transvaginal ultrasound at
- •Have any of the following abnormal cervical smear results at screening (based on
- •the 2001 Bethesda System [Solomon et al., 2002]):
- •- Atypical squamous cells of undetermined significance (ASC-US) present,
- •and human papilloma virus (HPV) reflex testing is positive for high risk
- •types or the testing outcome is unknown
- •- High-grade squamous intraepithelial lesion (HSIL) present
- •- Adenocarcinoma in situ (AIS) / malignant cells present
- •Have BMD with either lumbar spine or femur T-scores below -1.5 at screening as
- •determined by the central DXA facility or have a history of pathologic or compression
- •Have been pregnant within 6 months of the start of screening.
- •Are currently breastfeeding.
- •Are using systemic steroids on a chronic or regular basis within 3 months of the start
- •of screening.
- •Have a chronic, unstable endocrine abnormality causing dysregulation of the
- •hypothalamic-pituitary-gonadal axis that leads to ovarian dysfunction.
- •Have an unstable medical condition or chronic disease (including history of
- •neurological [including cognitive], psychological, hepatic, renal, cardiovascular, GI,
- •or pulmonary disease), irritable bowel syndrome, interstitial cystitis, or malignancy
- •that could confound interpretation of the study outcomes.
- •Have chronic pelvic pain that is not caused by endometriosis (e.g., uterine fibroids).
- •Have a history of poor compliance in clinical research studies.
- •Have a medically significant illness in the 30 days before the beginning of Week 1.
- •Have a clinically significant abnormality based on assessments at screening or the
- •beginning of Week 1.
- •Are using any investigational drug within 2 months of the start of screening.
- •Have a positive human immunodeficiency virus antibody (HIV-Ab), hepatitis B
- •surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) assay at screening
- •or have a history of a positive result.
- •Have an allergy, hypersensitivity, or intolerance to a GnRH agonist or antagonist.
研究者
相似试验
进行中（未招募）
不适用
A Phase II, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects with EndometriosisEndometriosisEUCTR2007-006474-28-BGeurocrine Biosciences, INC180
进行中（未招募）
不适用
A Phase II, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects with EndometriosisMedDRA version: 9.1Level: LLTClassification code 10014778Term: EndometriosisEndometriosisEUCTR2007-006474-28-HUeurocrine Biosciences, INC180
已完成
不适用
Efficacy and Safety of TAK-379 in Adult Subjects With Type 2 Diabetes MellitusPER-132-08TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
招募中
1 期
Phase 2 Study of Adjuvant V940 and Pembrolizumab in Muscle-invasive Urothelial CarcinomaHigh-risk Muscle-invasive Urothelial Carcinoma Post-radical ResectionMedDRA version: 20.0Level: LLTClassification code: 10064467Term: Urothelial carcinoma Class: 10029104CTIS2023-505658-17-00Merck Sharp & Dohme LLC220
进行中（未招募）
不适用
A Phase II, Randomised, Double-Blind, Placebo-controlled, Multi-centre Study to Investigate the Impact of Diamyd on the Progression of diabetes in Patients Newly Diagnosed with Type 1 Diabetes MellitusType 1 diabetesEUCTR2004-003764-30-SEDiamyd Therapeutics AB70