Status:
COMPLETED
Effect of Melatonin on Reduction of Pelvic Pain
Lead Sponsor:
Karolinska Institutet
Conditions:
Dysmenorrhea
Endometriosis
Eligibility:
FEMALE
18-55 years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- Dysmenorrhea group
- 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
- 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
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03782740
Start Date
March 15 2019
End Date
June 30 2021
Last Update
April 5 2022
Active Locations (1)
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1
Södersjukhuset
Stockholm, Sweden, 118 32