Effect of Melatonin on Reduction of Pelvic Pain

Karolinska Institutet80 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dysmenorrhea Endometriosis

Interventions

Melatonin 10 mgDRUG

Melatonin capsule

PlaceboDRUG

Sugar pill manufactured to mimic Melatonin capsule

Melatonin 20 mgDRUG

Melatonin capsule

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Södersjukhuset

Stockholm, Sweden

Outcomes

Primary Outcomes

Pain reduction

Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)

Time frame: 12 weeks

Secondary Outcomes

Use of analgesics

Self reported daily quantification of intake of analgesics reported online

Time frame: 12 weeks

Quality of sleep

Insomnia Severity index questionnaire will be administered during observational cycle and once during the second treatment cycle. 0 to 28 Points, 0-7 Points signifies no Clinical significant sleeping dificulties, 22-28 Points signifies Clinical insomnia)

Time frame: 12 weeks

Cognition

Dysmenorrhea group: Online test (CANTAB) performed on day 1-4 in the menstrual cycle in the observational cycle and in the second treatment cycle.

Time frame: 12 weeks

Catastrophic thinking

Endometriosis group: Pain Catastrophizing Scale questionnaire will be administered during observational cycle and once during the second treatment cycle. 0-52 Points, higher points indicate higher tendency to catastrophize.

Time frame: 12 weeks

General well being

Endometriosis group: Quality of life assessment with Endometriosis Health Profile (EHP-30) will be administered during observational cycle and once during the second treatment cycle. Score 0-100 Points, where 0 is best health status and 100 is worst health status.

Time frame: 12 weeks

Acceptance of Melatonin

Assessment at the end of study

Data from ClinicalTrials.gov

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