Vaginal ring repeated administration trial
Research type
Research Study
Full title
A double-blind, randomised, repeated administration trial investigating safety, tolerability and endocrine effects of quinagolide vaginal ring in healthy women with normal menstrual cycle.
IRAS ID
187717
Contact name
Vivian Kristoffersson
Contact email
Sponsor organisation
Ferring Pharmaceuticals A/S
Eudract number
2015-002813-31
Duration of Study in the UK
0 years, 5 months, 2 days
Research summary
This study is to investigate the safety and tolerability of two consecutively administered vaginal rings containing the same drug dose level during two menstrual periods as well as any effect of the study drug on ovarian function in healthy women with normal menstrual cycles. It is being developed for the treatment of endometriosis. \n\nThe study will enrol 28 healthy female volunteers aged 18 to 40 years. \n\nThe subjects will start with a run-in menstrual cycle without treatment to establish their individual normal bleeding pattern. After a full run-in cycle the first vaginal ring will be inserted on Day 7 after start of menstruation in the next cycle, and the second ring (same dose load) will be inserted Day 7 after start of menstruation in the subsequent cycle. \n\nTransvaginal ultrasounds, blood samples for hormone levels, swabs for vaginal micro flora, and PK samples will be taken repeatedly during the three cycles. Two endometrial biopsies will be taken for histology assessments, one in the run-in cycle and the second in the second treatment cycle.\n\nContinuous ECG for QT interval assessment will be collected from 48 hours before dosing to 48 hours after dosing. \n\nA follow up visit will involve a complete physical and gynaecological examination including TVU. Questionnaires for acceptability and diaries for bleeding pattern will be completed throughout the trial. The expected duration of the study for each volunteer will be up to approximately 5 months.\n
REC name
HSC REC A
REC reference
15/NI/0190
Date of REC Opinion
8 Oct 2015
REC opinion
Further Information Favourable Opinion