CTRI/2022/04/041959尚未招募4 期
A Prospective, Multi-Center, Single Arm, Phase IV Study to Assess the Safety and Efficacy of Dienogest Tablets in Management of Pelvic Pain Associated with Endometriosis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Patient is willing to provide written informed consent
- •2) Female patient aged greater or equal to 18 and less than or equal to 45 years at the time of signing of the informed consent
- •3) Patient of endometriosis with pelvic pain documented by USG or laparoscopy
- •4) Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective non hormonal methods of contraception to prevent pregnancy from study entry till the last dose of the study medication [Note Woman with childbearing potential are defined as those who are not surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation)]
排除标准
- •1.Patient with chronic pelvic pain that is not attributed to Endometriosis
- •2.Patient with clinically established need for primary surgical treatment of endometriosis
- •3.Patient with known or suspected pregnancy
- •4.Lactating women
- •5.Patient planning to conceive during the study period
- •6.Patient with functional ovarian cysts
- •7.Patient with uncontrolled hypertension (systolic blood pressure greater than or equal to 160 mmHg OR diastolic blood pressure greater than or equal to 100 mmHg)
- •8.Patient with active venous thromboembolic disorder
- •9.Patient with current or history of arterial or cardiovascular disease such as coronary artery disease, congestive heart failure, arrhythmias, stroke or congenital heart disease.
- •10.Patient with HbA1c greater than 9.0%
- •11.Patient with severe renal impairment (eGFR less than 30 ml/min/1.73 m2)
- •12.Patient with vascular involvement as a consequence of Diabetes Mellitus
- •13.Patient with presence of severe hepatic disease (Chronic: Child Pugh C; Acute: Fatty liver grade greater than1 and INR greater than 1.5)
- •14.Patient with history of severe hepatic disease with abnormal liver function
- •15.Patient with presence or history of liver tumors (benign or malignant)
- •16.Patient with any known OR suspected malignancies
- •17.Patient with undiagnosed abnormal vaginal bleeding
- •18.Patient suffering from ophthalmic vascular disease
- •19.Patient with current OR history of migraine with focal aura
- •20.Patient who is a known case of osteoporosis or who in opinion of investigator, is at increased risk of osteoporosis
- •21.Patient is a smoker and expresses inability to cease smoking during the study.
- •22.Patient with history of OR suffering from depression
- •23.Patient with history of HIV, Hepatitis B and HCV
- •24.Patient who is on steroids (eg danazol) or planning to take during the study.
- •25.Patient having intolerance, hypersensitivity or any contraindication to any of the study drug or other components.
- •26.Patient with current or recent substance abuse, including alcohol as per Diagnostic and Statistical Manual fifth edition criteria
- •27.Patient with history of participation in another clinical trial in the past 30 days of screening or planning to participate during the study
- •28.Patient who has a clinically significant disorder that, in the opinion of the investigator, would result in the participantâ??s inability to understand and comply with the requirements of the study.
- •29.Investigators, study personnel, sponsor representatives and their first degree relatives.
研究者
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