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 - nil

Dr Ravisha Aggarwal0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•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

•-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
•-Women with acquired/congenital uterine anomaly
•- Patient using any systemic steroids (topical steroids allowed) over 14 days or within 3
•- 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.

发起方

Dr Ravisha Aggarwal