drugset / Trial / NCT03782740
Effect of Melatonin on Reduction of Pelvic Pain
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2019-03-15
- Primary completion
- 2021-06-27
- Completion
- 2021-06-30
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 10 mg | Oral |
| Subject | Melatonin | Small molecule | 20 mg | Oral |