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NCT Number: NCT03782740

Effect of Melatonin on Reduction of Pelvic Pain

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.

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Key information

Conditions

Dysmenorrhea Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Södersjukhuset

Stockholm, 118 32, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 10 MG

Drug

Melatonin capsule

Other names: N-acetyl-5-methoxy tryptamine

Placebo

Drug

Sugar pill manufactured to mimic Melatonin capsule

Other names: Sugar pill

Melatonin 20 mg

Drug

Melatonin capsule

Other names: N-acetyl-5-methoxy tryptamine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2018
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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