DysmenorrheaPhase 2NCT03782740
Effect of Melatonin on Reduction of Pelvic Pain
A Phase 2 study testing Melatonin 10 mg and Melatonin 20 mg in people with Dysmenorrhea and Endometriosis, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Dysmenorrhea, Endometriosis
- What is being tested?
- Melatonin 10 mg and Melatonin 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2019to 30 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Regular menstrual cycles,
- Severe dysmenorrhea (NRS>6)
- Speaks and understands Swedish
- If other medication, those should be un-altered for the last 3 months
Who cannot join
- Smoker
- Prior or ongoing liver or kidney disease
- Endometriosis
- Pregnancy
- Endometriosis group:
- Criteria for inclusion:
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Dysmenorrhea, Endometriosis
- Being tested
- Melatonin 10 mg, Placebo, Melatonin 20 mg
- Medical subject headings
- Dysmenorrhea, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 10 mgDrug
Also called N-acetyl-5-methoxy tryptamine
Melatonin capsule
PlaceboDrug
Also called Sugar pill
Sugar pill manufactured to mimic Melatonin capsule
Melatonin 20 mgDrug
Also called N-acetyl-5-methoxy tryptamine
Melatonin capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Melatonin 10 mg; Drug: 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. Receives: Drug: Placebo; Drug: Melatonin 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)
Measured: 12 weeks
Secondary outcomes (7)
Use of analgesics
Self reported daily quantification of intake of analgesics reported online
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Acceptance of Melatonin
Assessment at the end of study
Measured: 12 weeks
Side effects of Melatonin
Online self reporting, daily
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start15 Mar 2019
- Primary completion27 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Marions, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782740
- Sponsor's protocol ID
- Mel PP
- Status last verified
- Apr 2022
- First submitted
- 14 Nov 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 37267394Soderman 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.
PubMed 34668986
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin on Reduction of Pelvic Pain
- ClinicalTrials.gov ID
- NCT03782740
- Acronym / sponsor ID
- Mel PP
- Conditions
- Dysmenorrhea, Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 27 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two parallel studies (dysmenorrhea and endometriosis) with 40 participants in each.
| Arm | Type | Receives |
|---|---|---|
| Dysmenorrhea Melatonin 10 mg | Experimental | Drug: Melatonin 10 mg, Drug: PlaceboIn 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 | Drug: Placebo, Drug: Melatonin 20 mgIn the endometriosis group: 4 capsules with 5 mg melatonin will be given every evening during eight weeks. Compared with placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Regular menstrual cycles,
- Severe dysmenorrhea (NRS>6)
- Speaks and understands Swedish
- If other medication, those should be un-altered for the last 3 months
Key exclusion criteria (17 listed)
- Smoker
- Prior or ongoing liver or kidney disease
- Endometriosis
- Pregnancy
- Endometriosis (endometriomas or diagnosis by laparoscopy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 10 mgAlso: N-acetyl-5-methoxy tryptamineMelatonin capsule | Drug | Dysmenorrhea Melatonin 10 mg |
| PlaceboAlso: Sugar pillSugar pill manufactured to mimic Melatonin capsule | Drug | Dysmenorrhea Melatonin 10 mg, Endometriosis Melatonin 20 mg |
| Melatonin 20 mgAlso: N-acetyl-5-methoxy tryptamineMelatonin capsule | Drug | Endometriosis Melatonin 20 mg |
Primary outcome
Pain reduction
Time frame: 12 weeks
Self reported pain intensity daily, Numeric Rating Scale (NRS) 0-10 (0=no pain, 10 = worst possible pain)
7 secondary outcomes
Use of analgesics
Time frame: 12 weeks
Quality of sleep
Time frame: 12 weeks
Cognition
Time frame: 12 weeks
Catastrophic thinking
Time frame: 12 weeks
General well being
Time frame: 12 weeks
Acceptance of Melatonin
Time frame: 12 weeks
Side effects of Melatonin
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 37267394Soderman 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.
- Derived from this study: PubMed 34668986Soderman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin 10 mg and Melatonin 20 mg in people with Dysmenorrhea and Endometriosis, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03782740, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.