Effect of Melatonin on Reduction of Pelvic Pain

NCT03782740 | Completed Phase 2 DMC

• 1 other identifier: Mel PP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea; Endometriosis

Outcome Measures

Primary Outcomes (1)

• Pain reduction

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

  12 weeks

Secondary Outcomes (7)

• Use of analgesics

  12 weeks

• Quality of sleep

  12 weeks

• Cognition

  12 weeks

• Catastrophic thinking

  12 weeks

• General well being

  12 weeks

Study Arms (2)

Dysmenorrhea Melatonin 10 mg

EXPERIMENTAL

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; Drug: Placebo

Endometriosis Melatonin 20 mg

EXPERIMENTAL

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

Drug: Placebo; Drug: Melatonin 20 mg

Interventions

Melatonin 10 mg DRUG

Melatonin capsule

Also known as: N-acetyl-5-methoxy tryptamine

Dysmenorrhea Melatonin 10 mg

Placebo DRUG

Sugar pill manufactured to mimic Melatonin capsule

Also known as: Sugar pill

Dysmenorrhea Melatonin 10 mg; Endometriosis Melatonin 20 mg

Melatonin 20 mg DRUG

Melatonin capsule

Also known as: N-acetyl-5-methoxy tryptamine

Endometriosis Melatonin 20 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Regular menstrual cycles,
• Severe dysmenorrhea (NRS\>6)
• Speaks and understands Swedish
• If other medication, those should be un-altered for the last 3 months

You may not qualify if:

• Smoker
• Prior or ongoing liver or kidney disease
• Endometriosis
• Pregnancy
• Endometriosis group:
• 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
• Prior or ongoing disease in kidney or liver
• Use of opioid analgesics
• Smoker
• Pregnant

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Södersjukhuset

Stockholm, 118 32, Sweden

Location

Related Publications (2)

• Soderman L, Bottiger Y, Edlund M, Jarnbert-Pettersson H, Marions L. Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain-A randomized double-blinded, placebo-controlled trial. PLoS One. 2023 Jun 2;18(6):e0286182. doi: 10.1371/journal.pone.0286182. eCollection 2023.

  PMID: 37267394 DERIVED

• 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.

  PMID: 34668986 DERIVED

MeSH Terms

Conditions

Dysmenorrhea; Endometriosis

Interventions

Melatonin; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: December 20, 2018
• Study Start: March 15, 2019
• Primary Completion: June 27, 2021
• Study Completion: June 30, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

SE (1)