Effect of Melatonin on Reduction of Pelvic Pain

Endometriosis Clinical Trial

Official title:

Effect of Melatonin on Reduction of Pelvic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782740
• Other study ID #: Mel PP
• Status: Completed
• Phase: Phase 2
• Start date: March 15, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2021
• Est. primary completion date: June 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Endometriosis
• Pelvic Pain

Intervention

Drug:
• Melatonin 10 mg
Melatonin capsule
• Placebo
Sugar pill manufactured to mimic Melatonin capsule
• Melatonin 20 mg
Melatonin capsule

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)	12 weeks
Secondary	Use of analgesics	Self reported daily quantification of intake of analgesics reported online	12 weeks
Secondary	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)	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	Acceptance of Melatonin	Assessment at the end of study	12 weeks
Secondary	Side effects of Melatonin	Online self reporting, daily	12 weeks