Clinical trial NCT03782740: Effect of Melatonin on Reduction of Pelvic Pain
Official title: Effect of Melatonin on Reduction of Pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysmenorrhea
Endometriosis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain reduction
timeFrame: 12 weeks
Secondary outcomes:
measure: Use of analgesics
timeFrame: 12 weeks
measure: Quality of sleep
timeFrame: 12 weeks
measure: Cognition
timeFrame: 12 weeks
measure: Catastrophic thinking
timeFrame: 12 weeks
measure: General well being
timeFrame: 12 weeks
measure: Acceptance of Melatonin
timeFrame: 12 weeks
measure: Side effects of Melatonin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
References:
citation: Soderman L, Edlund M, Bottiger Y, Marions L. Adjuvant use of melatonin for pain management in dysmenorrhea - a randomized double-blinded, placebo-controlled trial. Eur J Clin Pharmacol. 2022 Feb;78(2):191-196. doi: 10.1007/s00228-021-03234-6. Epub 2021 Oct 20.