NCT03782740

Effect of Melatonin on Reduction of Pelvic Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Two substudies will be performed. Forty women with severe dysmenorrhea will be randomized to treatment with 10 mg melatonin daily or placebo during the menstruation for 2 menstrual cycles. Another 40 women with endometriosis will be randomized to treatment with 20 mg or placebo daily during 8 weeks. Participants will report drug intake, bleeding details (duration and amount) and pain as well as possible side effects. They will also perform a test for sleep quality and cognition before and after completion of the study. See protocol for more details

Conditions

• Dysmenorrhea
• Endometriosis

Interventions

Type	Name	Description
DRUG	Melatonin 10 mg	Melatonin capsule
DRUG	Placebo	Sugar pill manufactured to mimic Melatonin capsule
DRUG	Melatonin 20 mg	Melatonin capsule

Timeline

• Start date: 2019-03-15
• Primary completion: 2021-06-27
• Completion: 2021-06-30
• First posted: 2018-12-20
• Last updated: 2022-04-05

Locations

1 site across 1 country: Sweden