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Effect of Melatonin on Reduction of Pelvic Pain

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ClinicalTrials.gov Identifier: NCT03782740
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Lena Marions, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Endometriosis Drug: Melatonin 10 mg Drug: Placebo Drug: Melatonin 20 mg Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Melatonin on Reduction of Pelvic Pain
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Dysmenorrhea Melatonin 10 mg
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
Melatonin capsule
Other Name: N-acetyl-5-methoxy tryptamine

Drug: Placebo
Sugar pill manufactured to mimic Melatonin capsule
Other Name: Sugar pill

Experimental: Endometriosis Melatonin 20 mg
In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo.
Drug: Placebo
Sugar pill manufactured to mimic Melatonin capsule
Other Name: Sugar pill

Drug: Melatonin 20 mg
Melatonin capsule
Other Name: N-acetyl-5-methoxy tryptamine




Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 12 weeks ]
    Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)


Secondary Outcome Measures :
  1. Use of analgesics [ Time Frame: 12 weeks ]
    Self reported daily quantification of intake of analgesics reported online

  2. Quality of sleep [ Time Frame: 12 weeks ]
    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)

  3. Cognition [ Time Frame: 12 weeks ]
    Dysmenorrhea group: Online test (CANTAB) performed on day 1-4 in the menstrual cycle in the observational cycle and in the second treatment cycle.

  4. Catastrophic thinking [ Time Frame: 12 weeks ]
    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.

  5. General well being [ Time Frame: 12 weeks ]
    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.

  6. Acceptance of Melatonin [ Time Frame: 12 weeks ]
    Assessment at the end of study

  7. Side effects of Melatonin [ Time Frame: 12 weeks ]
    Online self reporting, daily



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782740


Contacts
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Contact: Lena Marions, MD PhD 0046 8 616 15 32 lena.marions@ki.se

Locations
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Sweden
Södersjukhuset Recruiting
Stockholm, Sweden, 118 32
Sponsors and Collaborators
Karolinska Institutet
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Responsible Party: Lena Marions, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03782740    
Other Study ID Numbers: Mel PP
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Dysmenorrhea
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Menstruation Disturbances
Pathologic Processes
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants