Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Endometriosis is a chronic inflammatory disease, frequently associated with dysmenorrhea, dyspareunia and abdomino-pelvic pain limiting quality of life. Most medical therapies aim to alleviate the severity of symptoms. Recent guidelines recommend the use of either OCPs or progestins as a first-line treatment of pain associated with endometriosis. The effectiveness of both OCPs and dienogest, a fourth-generation progestin, for endometriosis treatment has been demonstrated. The literature is rich with data comparing the use of Visanne or OCPs to placebo or GnRH analogs. However, there are no head to head studies comparing their efficacy in the management of endometriosis associated pain. The study aims to evaluate if Dienogest (Visanne) is not inferior in efficacy to oral contraceptive pills (Yasmin) in controlling pain associated with endometriosis?

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Dienogest; Nandrolone

Criteria

Inclusion Criteria:

• Patients confirmed or suspected of endometriosis on clinical evaluation (VAS score more than 5 and presence of subjective symptoms), surgical or imaging studies, and not taking any pain killer or other hormonal treatment for the moment

• Age 20-45

• Regular menstrual cycles

• The presence of subjective symptoms during menstruation (at least one from among lower abdominal pain, lumbago, defecation pain, nausea, and headache)

• The presence of subjective symptoms during non-menstruation (at least one from among lower abdominal pain, lumbago, defecation pain, dyspareunia, and pain on internal examination).

Exclusion Criteria:

• Undiagnosed genital bleeding

• Use of any hormonal therapy for endometriosis within 16 weeks before enrollment

• A history of severe adverse drug reactions or hypersensitivity to steroid hormone

• Having undergone surgery therapy or surgical examination for endometriosis within a menstrual cycle before the start of medication

• Previous failure of treatment with the OCP used in the current study

• Contraindications to OCP or Dienogest use

• Smokers >35

• A history or complication of thrombosis/embolism

• Migraines with aura

• Depression

• Patients on anti-epileptics

• Diabetes Mellitus with vascular involvement

• Liver diseases

• Known or suspected sex hormone dependent malignancies

• Repeat surgery for endometriosis

• Patient consulting for infertility

• Pregnant or nursing

• Planning for pregnancy in near future.