PK/PD & safety of ulipristal acetate delivered from intravaginal ring
Research type
Research Study
Full title
A phase 1, randomised, double-blind, parallel group, placebo-controlled, 12-week treatment study to evaluate the pharmacokinetics, pharmacodynamics and safety of ulipristal acetate delivered from an intravaginal ring in healthy female subjects.
IRAS ID
223550
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
PregLem S.A.
Eudract number
2016-004445-93
Duration of Study in the UK
0 years, 8 months, 14 days
Research summary
We are conducting a study of PGL4001 (ulipristal acetate) in healthy female adult volunteers. Ulipristal acetate (UPA) delivered intravaginally is being developed by PregLem S.A. as a treatment for uterine fibroids. Fibroids are benign tumours that develop in the muscles of the uterus, causing heavy bleeding during and in-between the menstrual cycles. UPA is a steroid drug currently marketed in Europe in 5-mg oral tablets under the brand name Esmya®. This IVR is being developed as an alternative to oral tablets and because the vaginal lining rapidly absorbs steroids into the blood stream. Furthermore, drugs administered via the vaginal route avoid absorption and potential breakdown in the stomach, intestines and liver and therefore may be more available in the blood, making it a very effective route of administration. This makes it feasible to use lower doses while achieving the same local pharmacodynamic effect.\nIn this study, 35 women will be recruited and randomly allocated to receive either a 2-3mg/day, a 4-6mg/day or a placebo IVR. After a screening phase, eligible women will receive three IVRs, inserted consecutively for 3 treatment periods of 28 days (one ring per period) over 12 weeks. All volunteers will attend the unit for outpatient visits during each treatment period and will be followed up for three 3 months after the last IVR is removed. The overall duration of the study from screening to last visit is approximately 8 months for each volunteer.\nWe will collect blood samples for pharmacokinetic measurements and assess safety parameters including physical and gynaecological examinations, breast examinations, electrocardiogram (ECG), cervical smear, vital sign measurements, laboratory evaluations, and monitoring of adverse events (AEs). Volunteers will also have 3 endometrial biopsies, five transvaginal ultrasound scans and blood hormone tests for safety monitoring and also to assess pharmacodynamic effects of the drug.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/0307
Date of REC Opinion
31 May 2017
REC opinion
Favourable Opinion