Effect of Melatonin on Reduction of Pelvic Pain

NCT ID: NCT03782740

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2021-06-30

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

Conditions

Dysmenorrhea; Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Melatonin 10 mg

Intervention Type: DRUG

Melatonin capsule

Placebo

Intervention Type: DRUG

Sugar pill manufactured to mimic Melatonin capsule

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Sugar pill manufactured to mimic Melatonin capsule

Melatonin 20 mg

Intervention Type: DRUG

Melatonin capsule

Interventions

Melatonin 10 mg

Melatonin capsule

Intervention Type: DRUG

Placebo

Sugar pill manufactured to mimic Melatonin capsule

Intervention Type: DRUG

Melatonin 20 mg

Melatonin capsule

Intervention Type: DRUG

Other Intervention Names

N-acetyl-5-methoxy tryptamine; Sugar pill; N-acetyl-5-methoxy tryptamine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Lena Marions

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Södersjukhuset

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 37267394 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34668986 (View on PubMed)

Other Identifiers

Mel PP

Identifier Type: -

Identifier Source: org_study_id