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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysmenorrhea Melatonin 10 mg | Experimental | 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. |
|
| Endometriosis Melatonin 20 mg | Experimental | In the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 10 mg | Drug | Melatonin capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction | Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Use of analgesics | Self reported daily quantification of intake of analgesics reported online | 12 weeks |
| Quality of sleep | 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) |
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Dysmenorrhea group
Inclusion Criteria:
Exclusion Criteria:
Endometriosis group:
Criteria for inclusion:
Criteria for exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | 118 32 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37267394 | Derived | Soderman L, Bottiger Y, Edlund M, Jarnbert-Pettersson H, Marions L. Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain-A randomized double-blinded, placebo-controlled trial. PLoS One. 2023 Jun 2;18(6):e0286182. doi: 10.1371/journal.pone.0286182. eCollection 2023. | |
| 34668986 | Derived |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.
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| Placebo | Drug | Sugar pill manufactured to mimic Melatonin capsule |
|
|
| Melatonin 20 mg | Drug | Melatonin capsule |
|
|
| 12 weeks |
| Cognition | Dysmenorrhea group: Online test (CANTAB) performed on day 1-4 in the menstrual cycle in the observational cycle and in the second treatment cycle. | 12 weeks |
| Catastrophic thinking | 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. | 12 weeks |
| General well being | 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. | 12 weeks |
| Acceptance of Melatonin | Assessment at the end of study | 12 weeks |
| Side effects of Melatonin | Online self reporting, daily | 12 weeks |
| 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. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002241 | Carbohydrates |