Creator/Principal investigator(s)
Lena Marions - Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
Description
Purpose: Considering the pharmacological treatment options for endometriosis-associated pain are confined to hormonal therapy and analgesics, we studied the analgesic effect of 20 mg melatonin as an adjuvant therapy in women with endometriosis-associated pain.
Methods: This randomized double-blinded, placebo-controlled trial was conducted at the Research Center for Womens’ Health at Södersjukhuset, a university hospital in Stockholm, Sweden. Forty women from 18 to 50 years of age with endometriosis and severe dysmenorrhea with or without chronic pelvic pain were given 20 mg Melatonin or placebo orally daily for two consecutive menstrual cycles or months. The level of pain was recorded daily via questionnaire on the 11-point numeric rating scale. A difference of 1.3 units was considered clinically significant.
Clincaltrials.gov nr NCT03782740.
Results: Sixteen participants completed the study in the placebo group and 18 in the melatonin group. The difference in endometriosis-associated pain between the groups showed to be non-significant statistically as well as clinically.
Conclusion: This ra
Language
Swedish
Research principal
Responsible department/unit
Ki SÖS
Contributor(s)
Ylva Böttiger - University of Linköping, Department of Biomedical and Clinical Sciences
Hans Järnbert-Pettersson - Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
Måns Edlund - Karolinska Institutet, Department of Women's and Children's Health
Data contains personal data
Yes
Sensitive personal data
Yes
Type of personal data
pseudonymised
Code key exists
Yes
Ethics Review
Stockholm - Ref. 2017/1177-21/2
Population
Fyrtio kvinnor, 18-50 år med endometrios och svår mensvärk
Study design
Double-blind randomised trial
Geographic spread
Geographic location: Sweden
Associated documentation
Description
The dataset consists of a csv fil (RCT_mel_endo.csv) with responses from the survey.Version 1
https://doi.org/10.48723/875f-ma81
Citation
Download citation
Data format / data structure
Numeric
Creator/Principal investigator(s)
Lena Marions - Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset
Keywords
Number of individuals/objects
40