Effect of Melatonin on Reduction of Pelvic Pain

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Melatonin on Reduction of Pelvic Pain

Conditions
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Dysmenorrhea, Endometriosis

Intervention / Treatment
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* Drug: Melatonin 10 mg
* Drug: Placebo
* Drug: Melatonin 20 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dysmenorrhea Melatonin 10 mg<br>In the dysmenorrhea group: 2 capsules with 5 mg melatonin will be given in the evening for seven days consecutively during menstruation for two mentrual cycles. Compared with placebo. | Drug: Melatonin 10 mg<br>* Melatonin capsule<br>* Other names: N-acetyl-5-methoxy tryptamine;Drug: Placebo<br>* Sugar pill manufactured to mimic Melatonin capsule<br>* Other names: Sugar pill;|
| Experimental: Endometriosis Melatonin 20 mg<br>In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo. | Drug: Placebo<br>* Sugar pill manufactured to mimic Melatonin capsule<br>* Other names: Sugar pill;Drug: Melatonin 20 mg<br>* Melatonin capsule<br>* Other names: N-acetyl-5-methoxy tryptamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of analgesics | Self reported daily quantification of intake of analgesics reported online | 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) | 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. | 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. | 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. | 12 weeks | 
| Acceptance of Melatonin | Assessment at the end of study | 12 weeks | 
| Side effects of Melatonin | Online self reporting, daily | 12 weeks |