Effect of Melatonin on Reduction of Pelvic Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pain reduction
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
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.
Intervention: Melatonin 10 mg (Drug)
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.
Intervention: Placebo (Drug)
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.
Intervention: Placebo (Drug)
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.
Intervention: Melatonin 20 mg (Drug)
Outcomes
Primary Outcomes
Pain reduction
Time Frame: 12 weeks
Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)
Secondary Outcomes
- Cognition(12 weeks)
- Catastrophic thinking(12 weeks)
- Side effects of Melatonin(12 weeks)
- Use of analgesics(12 weeks)
- Quality of sleep(12 weeks)
- General well being(12 weeks)
- Acceptance of Melatonin(12 weeks)
Investigators
Lena Marions
Associate Professor
Karolinska Institutet