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Starting the study
If you are already taking hormones to treat POI, you will need to stop treatment for 4 weeks so we can assess your health without it.
Before starting study treatment, you'll have clinic tests (blood pressure, height, weight, bone density scan) and fill in questionnaires about your symptoms, lifestyle, and health.
The bone density measurement may be at a different time and/or location to the other tests. These initial tests will need to be completed at your treating clinic. During the bone density scan, you will need to lie still on your back on a flat, open x-ray table. This usually takes 10-20 minutes. The results will be discussed with you at your next clinic appointment.
Some clinics may offer optional blood, urine, or chromosome (genetic) tests to look at bone health and cardiovascular health in more detail. Results are shared at your next visit. You can still join the study without giving these samples should you prefer not to.
If you do choose to provide blood samples, you will have a morning appointment and will be asked to fast before the blood test is done. This means that you should have nothing to eat or drink except plain water for 12 hours before the blood test. However, you can continue to take any prescribed medications with water only. About 30ml (6 teaspoons) of blood will be taken for the tests.
Oestrogen treatment
After initial tests, you'll be randomly assigned to take either COC or HRT. This means that you cannot choose which treatment you take. Your study doctor will give you a prescription and you can start the treatment straight away.
If you are in the COC group, we recommend running 3 packs together, this will involve taking a daily tablet for 9 weeks, then a short break (4-7 days). Your study doctor can explain this and alternative ways to take it.
If you are in the HRT group, you will be asked whether you have a preference to take it as a tablet, patch or gel. If you have no preference, it will be randomly chosen for you. HRT usually includes oestrogen and progesterone, but if you've had a hysterectomy, you may only need oestrogen. HRT isn’t reliable contraception, non-hormonal methods are advised if relevant to you. Your study doctor will discuss the best option with you.
We know that some women will need to change their treatment during the study. It is possible to try different brands of COC or different types of HRT (e.g. tablet or patch) if you feel what you were first prescribed is not working for you. If this is the case please speak to your study doctor, who will discuss your options with you.
You’ll be asked to stay on your study treatment for at least 2 years and, if possible, we will keep in contact for up to 5 years. However, we know that some women may want to change or stop the allocated study treatment. We ask that you speak to your study doctor first before making changes. They can discuss it with you and inform your GP what to prescribe for you. If planning pregnancy, let them know so that they can support you.
Your study doctor will prescribe your treatment initially, and we will notify your GP so they can provide repeat prescriptions. HRT may incur prescription charges in England, but you can apply for an HRT pre-payment certificate (https://www.gov.uk/get-a-ppc/hrt-ppc). COC is free of charge.
Follow-up
Measuring your blood pressure and weight will be repeated at 3 months, 6 months, and 12 months, then yearly. These check-ups are usually done by your study team at the clinic, but your GP or pharmacy may help if needed.
You’ll also complete questionnaires about your symptoms, lifestyle, sexual activity, and work life. These are sent by email, or by post if you prefer. All your information will be kept safe and confidential.
Bone density scans will be repeated at 1 year, 2 years, and at 5 years if you are continuing in the study. These may require extra visits, and may be at a different place from your clinic, as they’re not always part of routine care.
If you’ve agreed to give blood and/or urine samples, these will be taken again at 3 months, 1 year, and at 2 years (blood only).
If you become pregnant or are planning pregnancy, please contact your study doctor.
With your permission, we will inform your General Practitioner (GP) about your participation in this trial.
Your name and telephone number will be shared with Esendex, our text messaging provider and their subprocessors, and will be used to send you text message reminders about the trial and trial questionnaires whilst you are participating in the trial.
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