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Effect of Melatonin on Reduction of Pelvic Pain

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ClinicalTrials.gov Identifier: NCT03782740
Recruitment Status : Active, not recruiting
First Posted : December 20, 2018
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Lena Marions, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE November 14, 2018
First Posted Date  ICMJE December 20, 2018
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE March 15, 2019
Estimated Primary Completion Date June 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
Pain reduction [ Time Frame: 12 weeks ]
Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Use of analgesics [ Time Frame: 12 weeks ]
    Self reported daily quantification of intake of analgesics reported online
  • 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)
  • 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.
  • 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.
  • 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.
  • Acceptance of Melatonin [ Time Frame: 12 weeks ]
    Assessment at the end of study
  • Side effects of Melatonin [ Time Frame: 12 weeks ]
    Online self reporting, daily
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Melatonin on Reduction of Pelvic Pain
Official Title  ICMJE Effect of Melatonin on Reduction of Pelvic Pain
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Dysmenorrhea
  • Endometriosis
Intervention  ICMJE
  • 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
  • Drug: Melatonin 20 mg
    Melatonin capsule
    Other Name: N-acetyl-5-methoxy tryptamine
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Melatonin 10 mg
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Melatonin 20 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 19, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date June 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03782740
Other Study ID Numbers  ICMJE Mel PP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lena Marions, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP