None listed
Conditions
Brief summary
Have received feedback which we are actively addressing to obtain HREC approval ERM Reference Number: 116499 Monash Health Reference: RES-25-0000-173A This study, called SLUMBER, is investigating whether melatonin—a natural hormone known to help regulate sleep—can improve sleep quality in women with endometriosis, a condition often linked to both pain and sleep disturbance. Participants will take either a placebo, 10 mg, or 20 mg of slow-release melatonin nightly for eight weeks. Researchers will assess changes in sleep, pain, and overall well-being through surveys completed before and after the trial. The study hypothesis is that melatonin use will lead to improved sleep quality, compared to placebo, in women with endometriosis.
Interventions
This clinical study is investigating the effects of slow-release melatonin on sleep disturbance in individuals with endometriosis. Participants are assigned to one of two groups receiving either 10mg or 20mg of slow-release melatonin, supplied from a compounding pharmacy and taken as an oral tablet one hour before bed for a period of eight weeks. To help monitor adherence, participants complete a brief weekly diary documenting their nightly use of the study medication. By comparing the two dosag
This clinical study is investigating the effects of slow-release melatonin on sleep disturbance in individuals with endometriosis. Participants are assigned to one of two groups receiving either 10mg or 20mg of slow-release melatonin, supplied from a compounding pharmacy and taken as an oral tablet one hour before bed for a period of eight weeks. To help monitor adherence, participants complete a brief weekly diary documenting their nightly use of the study medication. By comparing the two dosage arms, the study aims to evaluate both the safety and potential benefits of melatonin in managing endometriosis-related sleep disturbance.
Sponsors
Epworth Healthcare
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
• Current patient of a Julia Argyrou Endometriosis Centre at Epworth or Epworth gynaecology VMO • Greater than or equal to 18 years of age, pre-menopausal • Able to consent • Have a prior surgical/radiological diagnosis of endometriosis and are currently experiencing endometriosis-related symptoms • Be living in Australia • Access to internet • English speaking
Exclusion criteria
• Have a diagnosed sleep disorder • Patient plans to have surgery or to commence new therapy for endometriosis during the 8 week trial period • Have a known liver condition that requires specialist input or is associated with LFT derangement • Have an allergy to melatonin • Pregnant or breastfeeding or planning to conceive in the study period • Taking any other medications for sleep
Outcome results
None listed