INDessa - Proof-of-concept dose finding study with PD, PK and safety
Research type
Research Study
Full title
Multi-center, randomized, comparator-controlled, single-blind, parallel-group study to investigate the pharmacodynamics, pharmacokinetics and safety of an intrauterine system (BAY 987443) with three different release rates of indomethacin and one release rate of levonorgestrel, as compared with Jaydess, in a combined proof-of-concept and dose finding study in healthy pre-menopausal women treated for 90 days
IRAS ID
249721
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Bayer AG, Research & Development, Pharmaceuticals
Eudract number
2018-000128-33
Duration of Study in the UK
0 years, 9 months, 22 days
Research summary
This is a single-blind study in healthy pre-menopausal women aged 18–45 years with a history of regular menstrual cycles. Four different types of Intrauterine Systems (IUSs) will be administered in four treatment groups. Three of the treatment groups will involve different formulations of BAY 987443 (i.e. with different indomethacin [IND] concentrations and daily release rates, i.e. high, middle and low and all will use identical levonorgestrel [LNG] concentrations and release dates). The fourth group will use a comparator (Jaydess).
A total of 176 are planned to be randomized in the study (44 per treatment arm). 144 subjects evaluable per group.
Each treatment group will be divided into 2 subgroups: Subgroup 1 will involve a dense PK sampling scheme (for non-compartmental analysis [NCA] of pharmacokinetics [PK]).Subgroup 2 will involve sparse PK sampling scheme (for population PK analysis [pop PK]).
Subgroup 1 will consist of 12 subjects per dose group, Subgroup 2 will consist of 24 subjects per dose group.The study will consist of two parts (Part 1 and Part 2).
In Part 1, all subjects of the high dose IND group will be compared to half of the subjects in the comparator (Jaydess) group.
In Part 2, subjects will be randomized to the low and middle doses Combi IUS or the comparator (LNG only, i.e. Jaydess) group. Once all subjects of study Part 1 have completed treatment, an interim data evaluation will take place during which enrolment for study part 2 will continue. In case the sponsor decides to discontinue the study based on the stop criteria, subjects who are already in the treatment period of study part 2 will be offered to either continue the use of the study drugs until the end of the planned 90-day treatment period or have the IUS removed. No women will start a treatment once the decision to discontinue the study has been taken.The total duration of the study will be approximately 7 months per subject; which includes screening and follow-up phase.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/1375
Date of REC Opinion
30 Aug 2018
REC opinion
Unfavourable Opinion