Status:
COMPLETED
A Clinical Trial to Evaluate Dichloroacetate (DCA) as a Treatment for Endometriosis-associated Pain
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
University of Nottingham
Ferring Pharmaceuticals
Conditions:
Endometriosis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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
Detailed Description
Endometriosis is a chronic condition usually affecting women throughout their reproductive lives. It is defined as a growth of endometrial-like tissue (womb lining) outside the uterus (womb) and is as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04046081
Start Date
November 19 2019
End Date
September 30 2021
Last Update
June 13 2024
Active Locations (1)
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1
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom