Effect of Melatonin on Reduction of Pelvic Pain

Karolinska Institute

Status and phase: Completed; Phase 2

Conditions: Dysmenorrhea; Endometriosis

Treatments: Drug: Melatonin 20 mg; Drug: Melatonin 10 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03782740

Mel PP

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups

Dysmenorrhea Melatonin 10 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Melatonin 10 mg

Endometriosis Melatonin 20 mg

Experimental group

Description:

In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo.

Treatment:

Drug: Placebo

Drug: Melatonin 20 mg