A Phase 2 interventional study of Melatonin 10 mg and Placebo in Dysmenorrhea and Endometriosis, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Karolinska Institutet · Phase 2, Interventional, and Treatment
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.
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
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 80 is above the median of 64 across 525 interventional studies indexed under Endometriosis.
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Dysmenorrhea group
Inclusion Criteria:
Exclusion Criteria:
Endometriosis group:
Criteria for inclusion:
Criteria for exclusion:
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
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
Melatonin capsule
Also known as: N-acetyl-5-methoxy tryptamine
Sugar pill manufactured to mimic Melatonin capsule
Also known as: Sugar pill
Melatonin capsule
Also known as: N-acetyl-5-methoxy tryptamine
Pain reduction
Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)
Time frame: 12 weeks
Use of analgesics
Self reported daily quantification of intake of analgesics reported online
Time frame: 12 weeks
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)
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Acceptance of Melatonin
Assessment at the end of study
Time frame: 12 weeks
Side effects of Melatonin
Online self reporting, daily
Time frame: 12 weeks
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet