drugset / Trial / NCT03782740

Effect of Melatonin on Reduction of Pelvic Pain

NCT03782740

Phase 2 Completed 80 enrolled Karolinska Institutet
RandomizedParallel-groupTriple-blindTreatment

Summary

In two double blinded randomized controlled trials (RCT) we will study the effect of pain reduction of melatonin vs placebo in women with severe dysmenorrhea and women with endometriosis.The aim is to find an effective method for pelvic pain caused by dysmenorrhea and endometriosis.The primary outcome is reduction of pain in patients with dysmenorrhea and endometriosis respectively when treated with melatonin vs placebo. Secondary outcomes include the effect on daily life, quality of life and cognition. Sleep will also be assessed to evaluate its potential relation to quality of life and cognition.

Timeline

Start
2019-03-15
Primary completion
2021-06-27
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 10 mg Oral
Subject Melatonin Small molecule 20 mg Oral