Effect of Melatonin on Reduction of Pelvic Pain

Phase 2

Completed

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

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Endometriosis group:

Criteria for inclusion:

Criteria for exclusion:

Arm && Interventions

Group	Intervention	Description
Dysmenorrhea Melatonin 10 mg	Placebo	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.
Endometriosis Melatonin 20 mg	Placebo	In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo.
Endometriosis Melatonin 20 mg	Melatonin 20 mg	In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo.
Dysmenorrhea Melatonin 10 mg	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.

Primary Outcome Measures

Name	Time	Method
Pain reduction	12 weeks	Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)

Secondary Outcome Measures

Name	Time	Method
Side effects of Melatonin	12 weeks	Online self reporting, daily
Cognition	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.
Catastrophic thinking	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.
Use of analgesics	12 weeks	Self reported daily quantification of intake of analgesics reported online
Quality of sleep	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)
General well being	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.
Acceptance of Melatonin	12 weeks	Assessment at the end of study