NEW clinical trial for healthy females aged between 18 and 45. Get paid for your time!
We are carrying out a clinical trial with an investigational drug that is being developed for the treatment of uterine fibroids, i.e. benign tumours which develop in the uterus causing pelvic pain, pressure on other organs and heavy bleeding both during and between menstrual cycles. The study drug will be delivered intravaginally, through a ring-shaped device, and intends to regulate the activities of a hormone, known as progesterone, via its receptor in the uterus which should help to treat the symptoms of uterine fibroids. The results of this study will help us to plan for future clinical trials in patients.Register your interest in this clinical trial
This study will be conducted at our clinical trials unit in London Bridge and will involve healthy pre-menopausal female volunteers aged 18-45.
You will need to attend 2 screening appointments within 59 days prior to admission. If successful, you will be required to attend our unit for 3 in-house stays of 3 days/2 nights each and 23 short outpatient visits.
- Screening for this trial takes starts towards the end of August and admission commences at the end of September.
- You will attend your first screening appointment at our London Bridge facility on Day 2-4 of your menstrual cycle.
- Your second screening appointment will take place between days 10-18 of your menstrual cycle and will be with a gynaecologist based on Harley Street in London. If you are then placed onto the study you will see your gynaecologist regularly throughout the duration of the study. Travel costs will be covered separately for all visits to the gynaecologist.
- If your screening appointments are successful you will be placed onto the study one month after your screening process has been completed.
Further details of dates for this study will be released soon.
Who can take part?
To be eligible to take part in this study you must fit the following criteria:
- Healthy pre-menopausal females aged between 18 and 45 (inclusive) with Follicle-stimulating hormonal levels (FSH) ≤20mIU/ml
- You must have a Body Mass Index (BMI) within the range 18.0-30.0 kg/m² (inclusive)
- You must have menstrual cycles of 24 to 35 days (at least in the last 2 months prior to entering the study)
- You must not be pregnant or breastfeeding
- You must not currently be using any form of hormonal contraception (oral, transdermal, injectable, implanted or intravaginal) OR intrauterine devices/systems (IUDs or the IUS) with at least one complete spontaneous menstrual cycle (2 menses) since hormonal contraception was stopped/the IUD was removed
- You must not drink more than 8 cups per day of beverage containing caffeine
- You are a light smoker (less than 10 cigarettes or equivalent per day) or a non-smoker and be willing not to smoke whilst resident in the clinical unit
- You must not test positive for hepatitis B/C, HIV, alcohol or drugs or show any evidence of drug or alcohol abuse within the last 12 months. (Alcohol abuse is defined as a regular weekly intake of more than 14 units)
- You must be healthy with no underlying medical conditions that may either interfere with participation in the clinical study, and/or put you at any significant risk
- You must not be on any regular medications, including over the counter medications
- You must not have donated blood within 90 days prior to first dosing
- You must not have any history of heart-related diseases or abnormalities that show up on your ECGs
- You are of childbearing potential, heterosexually active and must agree to use contraceptive measures starting at screening and continuing until completion of your final follow up on Visit 29
A full list of acceptable contraceptive methods will be discussed in full by a member of the recruitment team and a study doctor during screening.
In recognition of the time involved in taking part in this study, you will receive £4,022 (£1,207 bonus and £2,815 study payment) on completion of the study provided you comply fully with all the study requirements.
- The study payments will paid to volunteers in instalments throughout the duration of the study.
- Travel costs for visits to the gynaecologist will be covered separately.
Get in touch
Call our team for more information: +44 (0) 20 7042 5800 (opt 1)
We are open weekdays 9am-5pm
or email us: firstname.lastname@example.org
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The contents of this advert have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.