A Clinical Trial to Evaluate Dichloroacetate (DCA) as a Treatment for Endometriosis-associated Pain

• Status: Recruiting
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

This is a single-arm open label exploratory clinical trial to evaluate dichloroacetate (DCA) as a possible treatment for treatment of endometriosis-associated pain

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Edinburgh
• Collaborators: Ferring Pharmaceuticals; University of Birmingham; University of Nottingham

Criteria

Inclusion Criteria:

• Women aged 18 or over

• Weight between 50 and 100kg

• Pre-menopausal

• Superficial peritoneal endometriosis (ASRM Stage I or II) at laparoscopy, performed within the last three years (and >2 weeks from surgery)

• Pelvic pain for longer than six months

• Average pain score of ≥ 4 over the four weeks prior to treatment

• Willing to comply with the treatment

• Willing to use contraception throughout the trial

• Willing and able to complete informed consent

Exclusion Criteria:

• Evidence of ovarian endometrioma or deep endometriosis (based upon current surgical staging or most recent imaging)

• Women who are pregnant or actively trying to get pregnant

• Known allergy or hypersensitivity to any excipient of DCA

• Breastfeeding

• Clinical evidence of pre-existing neuropathy

• Diabetes

• History of liver disease

• History of kidney disease

• Taking part in a CTIMP or other interventional non-CTIMP studies

• Patient on combination antiretroviral therapy

• History of malabsorption syndrome or substantial amount of small bowels or stomach removed