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NCT03782740
Effect of Melatonin on Reduction of Pelvic Pain
Phase 2 trial testing Melatonin 10 mg in Dysmenorrhea in 80 participants. Completed in 30 June 2021.
27 June 2021
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 15 March 2019 |
| Primary completion | 27 June 2021 |
| Estimated completion | 30 June 2021 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Melatonin 10 mg — full drug profile →
- Placebo
- Melatonin 20 mg — full drug profile →
Conditions studied
- Dysmenorrhea — all drugs for Dysmenorrhea →
- Endometriosis — all drugs for Endometriosis →
Sponsor
Karolinska Institutet
Who can join
Adults 18 to 55, female only, with Dysmenorrhea or Endometriosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pharmaceuticals targeting signaling pathways of endometriosis as potential new medical treatment: A review.
Hung SW, Zhang R, Tan Z, Chung JPW, et al · · 2021 · cited 120× · PMID 33948974 · DOI 10.1002/med.21802 -
Endometriosis and pain in the adolescent- striking early to limit suffering: A narrative review.
Sieberg CB, Lunde CE, Borsook D. · · 2020 · cited 29× · PMID 31862211 · DOI 10.1016/j.neubiorev.2019.12.004 -
Adjuvant use of melatonin for pain management in endometriosis-associated pelvic pain-A randomized double-blinded, placebo-controlled trial.
Söderman L, Böttiger Y, Edlund M, Järnbert-Pettersson H, et al · · 2023 · cited 13× · PMID 37267394 · DOI 10.1371/journal.pone.0286182 -
Adjuvant use of melatonin for pain management in dysmenorrhea - a randomized double-blinded, placebo-controlled trial.
Söderman L, Edlund M, Böttiger Y, Marions L. · · 2022 · cited 12× · PMID 34668986 · DOI 10.1007/s00228-021-03234-6 -
The Hallmarks of Endometriosis.
Psilopatis I, Burghaus S, Au K, Hofbeck L, et al · · 2024 · cited 6× · PMID 38884026 · DOI 10.1055/a-2306-8759
Verify or expand the search:
- PubMed search for NCT03782740
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03782740 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karolinska Institutet
- Last refreshed: 5 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03782740.
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