Dysmenorrhea, Endometriosis
Conditions
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
Interventions
DRUGMelatonin 10 mg
Melatonin capsule
DRUGPlacebo
Sugar pill manufactured to mimic Melatonin capsule
DRUGMelatonin 20 mg
Melatonin capsule
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction | 12 weeks | Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| Acceptance of Melatonin | 12 weeks | Assessment at the end of study |
| Side effects of Melatonin | 12 weeks | Online self reporting, daily |
| 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. |
Countries
Sweden
Outcome results
None listed