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Effect of Melatonin on Reduction of Pelvic Pain

NCT03782740 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-04-05

No results posted yet for this study

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.

Conditions

  • Dysmenorrhea
  • Endometriosis

Interventions

DRUG

Melatonin 10 mg

Melatonin capsule

DRUG

Placebo

Sugar pill manufactured to mimic Melatonin capsule

DRUG

Melatonin 20 mg

Melatonin capsule

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782740 on ClinicalTrials.gov