Effect of Melatonin on Reduction of Pelvic Pain

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: Melatonin

Criteria

Dysmenorrhea group

Inclusion Criteria:

• Regular menstrual cycles,

• Severe dysmenorrhea (NRS>6)

• Speaks and understands Swedish

• If other medication, those should be un-altered for the last 3 months

Exclusion Criteria:

• Smoker

• Prior or ongoing liver or kidney disease

• Endometriosis

• Pregnancy

Endometriosis group:

Criteria for inclusion:

• Endometriosis (endometriomas or diagnosis by laparoscopy)

• Moderate to severe pain (NRS >/= 4)

• Good general health

• Understands and speaks Swedish

• If any other treatment, unchanged regimen for the last 3 months

• Signed informed consent

Criteria for exclusion:

• Prior or ongoing disease in kidney or liver

• Use of opioid analgesics

• Smoker

• Pregnant