A PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AMY109 IN WOMEN WITH ENDOMETRIOSIS
Research type
Research Study
Full title
A Phase II, randomized, double blind study to evaluate the efficacy and safety of AMY109 in women with endometriosis
IRAS ID
1006385
Contact name
Edward Morris
Contact email
Sponsor organisation
Chugai Pharmaceutical Co.,Ltd.
Eudract number
2021-006583-24
ISRCTN Number
ISRCTN15654320
Research summary
This study is to evaluate the safety and efficacy (how well a drug works) of a drug called AMY109 in participants with endometriosis. The study is being conducted to understand how effective AMY109 and AMY109 in combination with a hormone contraceptive medication called desogestrel is in treating endometriosis, compared with desogestrel on its own.
Approximately 80 women will participate from 3-5 centres in the United Kingdom.
Potential participants may be able to take part if they:
- Are female aged 18-45
- Have endometriosis previously diagnosed by laparoscopy (incision made in the abdomen and a thin tube with a camera (laparoscope) inserted to look for lesions, adhesions and endometrioma (cyst/s)).
- Willing to have laparoscopic surgery after study treatment.There are four periods in this study:
Period 1: 4–12-week washout period, required for participants receiving certain types of medication.
Period 2: 21–45-day screening period, to confirm participant eligibility for the study.
Period 3: 52-week treatment period, for participants to receive study treatment.
Period 4: a post-treatment follow-up period, 52 weeks after the last dose of study drug to assess long-term safety of AMY109.Participants will be randomised in a 3:3:2 ratio to one of the following treatment groups:
AMY109, and desogestrel-placebo. A placebo looks like a medicine but does not contain any active ingredients
AMY109 and desogestrel
AMY109-placebo and desogestrel
AMY109 or AMY109-placebo will be administered every 4 weeks intravenously (directly into the vein)
Desogestrel will be administered daily orally (by mouth).The main assessments that will be performed include: a transvaginal ultrasound, MRI scan and post-treatment laparoscopy. Biological samples will be taken (including blood, urine, tissue and peritoneal fluid).
The total duration of the study will be approximately 29 months.
The study is being funded by Chugai Pharmaceutical Co., Ltd
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0214
Date of REC Opinion
30 Mar 2023
REC opinion
Further Information Favourable Opinion