An open label randomized clinical trial to compare the efficacy of Dienogest versus combined oral contraceptive pills (OCPs) using visual analog scale (VAS) for relief of pain associated with Endometriosis
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Changes in patient pain symptoms assessed by visual analog pain scale (VAS).
研究概览
简要总结
This study aimed to compare the efficacy and safety profile of Dienogest with Combined Oral Contraceptive pills for the relief of endometriosis-associated pelvic pain. Dienogest is a new generation of progestin used in the treatment of endometriosis. Given the chronic nature of the condition, medical treatments for endometriosis need to balance clinical efficacy and symptom relief with an acceptable long-term safety profile and OCPS cannot be taken by very young and older women due to estrogenic side effects or contraindications. Many recent guidelines have recommended the use of either COCs or progestins as a first line medical management for pain associated with endometriosis. Also very few studies have been done to compare the efficacy and safety profile of Dienogest vs Combined Oral Contraceptive pills
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient having diagnosis of endometriosis established by means of documented surgical visual (laparoscopy/laparotomy) or imaging (USG/MRI) plus Presence of at least one of the symptoms dysmenorrhea, chronic pelvic pain or both or dyspareunia for more than 6 months with.
- •Age: 18–45 years old.
- •Endometriosis associated pelvic pain scoring more than or equal to 4 On visual analog scale (VAS) at baseline.
- •Patients planned for medical management only for atleast 12 weeks.
- •Women willing to participate for study.
排除标准
- •Those who underwent surgery for endometriosis in between medical management.
- •Undiagnosed genital bleeding or other medical disorder like thyroid, bleeding disorder, liver and heart disease.
- •Use of hormonal therapy for endometriosis within 16 weeks before enrolment including GNRH antagonists, Depot Medroxyprogesterone acetate (DMPA), progestogens, OCPs or Previously, failed treatment of endometriosis using medications included in the study.
- •Pregnancy, lactation, and desire to conceive during treatment period.
- •Hypersensitivity to steroid hormones, Contraindications to COC or Dienogest use as recognized by the World Health Organization and Centers for Disease Control and Prevention -Women with acquired/congenital uterine anomaly.
- •Patient using any systemic steroids (topical steroids allowed) over 14 days or within 3 months.
- •Patient has chronic pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy which could interfere with assessment of pain.
- •Patient having positive history of HIV, HCV and HBV or active vaginal infection.
- •Patient having history of major depression or other psychiatric disorder (stroke).
- •Previous h/o severe life threatening or other significant sensitivity for any drug.
结局指标
主要结局
Changes in patient pain symptoms assessed by visual analog pain scale (VAS).
时间窗: Every 4 weeks till 12 weeks and after 1 month of stopping drug.
次要结局
- Comparison of adverse effect of drugs in both the groups.
研究者
Dr. Ravisha Aggarwal
All india institute of medical sciences Raipur