LPRI-CF113 Endometriosis
Research type
Research Study
Full title
A multicentre, phase III, double-blind, randomised clinical trial to assess the efficacy and safety of LPRI-CF113 in the treatment of Endometriosis versus placebo after 3 medication cycles followed by 3 open-label medication cycles
IRAS ID
1005172
Contact name
Enrico Colli
Contact email
Sponsor organisation
Chemo Research S. L.
Eudract number
2021-001424-17
Research summary
Research Summary
The study is aiming to test whether LPRI-CF113 can help in Endometriosis patients within 6 cycles.
Summary of Results
The primary objective of this clinical trial was to demonstrate whether the active study treatment, known as LPRI-CF113 would be safe and effective in the management of Endometriosis Associated Pelvic Pain (EAPP). LPRI-CF113 is a Progestogen-only pill (POP), a type of treatment traditionally used for the prevention of pregnancy, however POP’s are also suggested as a treatment of oestrogen dependent endometriosis. Subjects taking part in the study recorded their endometriosis associated pelvic pain on a numerical rating scale from 0-10 (0 being no pain experienced, and 10 being maximum pain experienced) via an e-diary. To be included in the trial, amongst other criteria subjects had a confirmed diagnosis of endometriosis and had experienced an EAPP score of >3 for at least 3 months before they started the trial. The subjects took the active study treatment or placebo once daily for 3 x 28 day consecutive cycles (the subject or study doctor/team did not know which treatment the subjects were assigned to as this was selected at random and blinded to avoid any bias in the results. Following this, subjects went on to an ‘open-label’ further 3 x 28 day consecutive cycle of the active treatment. Subjects were told they were receiving the active treatment, rather than placebo during this part of the trial. The results showed that the treatment of LPRI-CF113 over the 6 medication cycles was well tolerated and safe in subjects with endometriosis and the treatment was effective in the treatment of Endometriosis Associated Pelvic Pain. The results also showed a decrease or absence or bleeding or spotting, which can be considered as one of the reasons for pain relief. Furthermore, for subjects who were taking the LPRI-CF113 active treatment from cycle 1, the positive effect on EAPP scores was shown after one treatment cycle, which continued to improve until the end of the 6th cycle of treatment. Similar positive improvements to subjects’ EAPP scores were found for the subjects who switched from the placebo treatment to the active LPRI-CF113 treatment from cycle 3 to the end of the 6th cycle. Further details about the study can be found here: Clinical Trials register - Search for 2021-001424-17
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0159
Date of REC Opinion
12 Oct 2022
REC opinion
Further Information Favourable Opinion