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Effect of Melatonin on Reduction of Pelvic Pain

Primary Purpose

Dysmenorrhea, Endometriosis

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Melatonin 10 mg
Placebo
Melatonin 20 mg
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dysmenorrhea Melatonin 10 mg

Endometriosis Melatonin 20 mg

Arm Description

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.

In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Use of analgesics
Self reported daily quantification of intake of analgesics reported online
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)
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.
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.
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.
Acceptance of Melatonin
Assessment at the end of study
Side effects of Melatonin
Online self reporting, daily

Full Information

First Posted
November 14, 2018
Last Updated
April 4, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03782740
Brief Title
Effect of Melatonin on Reduction of Pelvic Pain
Official Title
Effect of Melatonin on Reduction of Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
June 27, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea, Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dysmenorrhea Melatonin 10 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Endometriosis Melatonin 20 mg
Arm Type
Experimental
Arm Description
In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo.
Intervention Type
Drug
Intervention Name(s)
Melatonin 10 mg
Other Intervention Name(s)
N-acetyl-5-methoxy tryptamine
Intervention Description
Melatonin capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Sugar pill manufactured to mimic Melatonin capsule
Intervention Type
Drug
Intervention Name(s)
Melatonin 20 mg
Other Intervention Name(s)
N-acetyl-5-methoxy tryptamine
Intervention Description
Melatonin capsule
Primary Outcome Measure Information:
Title
Pain reduction
Description
Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Use of analgesics
Description
Self reported daily quantification of intake of analgesics reported online
Time Frame
12 weeks
Title
Quality of sleep
Description
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
Title
Cognition
Description
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
Title
Catastrophic thinking
Description
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
Title
General well being
Description
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
Title
Acceptance of Melatonin
Description
Assessment at the end of study
Time Frame
12 weeks
Title
Side effects of Melatonin
Description
Online self reporting, daily
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
118 32
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34668986
Citation
Soderman L, Edlund M, Bottiger Y, Marions L. Adjuvant use of melatonin for pain management in dysmenorrhea - a randomized double-blinded, placebo-controlled trial. Eur J Clin Pharmacol. 2022 Feb;78(2):191-196. doi: 10.1007/s00228-021-03234-6. Epub 2021 Oct 20.
Results Reference
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Effect of Melatonin on Reduction of Pelvic Pain

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