Palmitoylethanolamide and polydatin effect on pain and dysmenorrhea in women scheduled for laparoscopic treatment of possible endometriosis: a double blind randomised controlled trial.
Phase 3
Recruiting
- Conditions
- EndometriosisPersistent pelvic painAnaesthesiology - Pain managementReproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12620001311943
- Lead Sponsor
- The University of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 260
Inclusion Criteria
Women aged 18 – 45 with pelvic pain scheduled for laparoscopic treatment of possible endometriosis. Both women with and without previous evidence of endometriosis on ultrasound or previous surgery are eligible
- Women who agree to use any type of contraception and avoid conceiving during the 8-week treatment phase.
- English speakers
Exclusion Criteria
Pregnancy or actively trying to conceive
Breastfeeding
Previous hysterectomy
Suspected malignancy
Inability to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the change in dysmenorrhoea visual analogue scale (VAS) score between PEA/PLD and placebo treatment in patients with endometriosis prior to laparoscopic surgical treatment.[After 8 weeks of post commencement of intervention (pre surgery)];To compare the change in dyspareunia VAS score between PEA/PLD and placebo treatment in patients with endometriosis prior to laparoscopic surgical treatment.[After 8 weeks of post commencement of intervention (pre surgery)];To compare the change in dyschezia VAS score between PEA/PLD and placebo treatment in patients with endometriosis prior to laparoscopic surgical treatment.<br><br>[After 8 weeks of post commencement of intervention (pre surgery)]
- Secondary Outcome Measures
Name Time Method