Information for women
Summary of the study
- Women with POI are treated with either the combined oral contraceptive pill (COC) or hormone replacement therapy (HRT). Both are recommended treatments.
- Women with POI need to take treatment until at least the average age of menopause, which is around the age of 51. This is because in women with POI, the body stops producing normal levels of certain hormones that need to be replaced to protect from long term health risks.
- We want to find out which treatment is best for relief of symptoms and reducing the long-term health risks of POI.
- If you are able to take part in the study, you will receive either HRT or COC (we will call this your study treatment). Neither you nor your doctor will be able to choose which treatment you receive.
- We would like you to continue to take part in the study for at least 5 years. However, you will be free to withdraw at any time if you wish.
- During the study you will be asked to complete questionnaires on your symptoms, sexual activity, lifestyle and working life.
- You will have your bone density measured and checks of your blood pressure and weight. You may need to make extra clinic visits for this.
- If you are in England and taking HRT as your study treatment you will be offered a total of £100 in vouchers for your continued participation throughout the study (£50 at the start of the study and £50 after 2 years of participation) as a contribution towards your prescription costs.
- The patient support groups the Daisy Network and the Turner’s Syndrome Society UK are actively supporting this study.
- All information collected during the course of the study will be kept safe and confidential.
Further information:
Please click the headings below
What is the purpose of the study?
When menopause occurs in women under the age of 40, it is termed POI. Your doctor will have discussed the diagnosis with you and the possible reasons why it has happened.The main symptom of POI is absent or very irregular periods. Many women get other menopause symptoms, such as hot flushes and sweats, loss of libido (sexual drive), painful intercourse, mood changes and tiredness. The ability to get pregnant naturally is greatly reduced.
The impact of symptoms and infertility can be distressing.In the long-term, women with POI are at higher risk of bone thinning (osteoporosis), fractures, heart disease and memory problems compared with women who experience menopause at the typical age, around 51 years. Treatments involve taking hormones, either in the form of HRT or COC.
There are benefits and risks of each treatment and healthcare professionals are uncertain which is the best for relief of symptoms and which is more effective in protecting against long term health risks, such as reduced bone density (bone thinning). The aim of this study is to find out what is the best treatment for women with POI in the short and long term.
Why have I been asked to take part?
You have been invited to take part in this study as you have been diagnosed with POI. We are looking for a total of 480 women to take part from throughout the United Kingdom. If you are planning to become pregnant within the next 12 months you will not be able to take part.
What would taking part involve?
If you are already taking treatment for your POI, you will be asked to stop taking this for 4 weeks. This is so that we can assess how you are without any treatment.
You will need to have some tests to assess your health before you start the study treatment. You will have your blood pressure, height, weight and bone density measured. The bone density measurement may be at a different time and/or location to the other tests. 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.
You will also be asked to complete questionnaires about your treatment, symptoms, lifestyle, pregnancy status as well as the impact POI has on your sexual activity and your working life.
In a few clinics, women are also being invited to provide blood and urine samples to look at their bone and heart health in more detail. In these clinics, women with an unknown cause of their POI who have not had their chromosomes analysed will also be offered the opportunity to be tested. Results of the test will be provided to you at your next follow-up appointment.
Providing blood and urine samples is optional and your doctor will advise you if this is happening at your clinic. If you are happy to give blood samples, we will take about 30 ml of blood for each sample, which is the equivalent of about 6 teaspoons. You can still take part in the study even if you do not want to provide blood and/or urine samples. You will be asked to fast prior to the blood test being performed. 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 medication with water only. Your appointment will be made as early in the morning as possible where fasting is required.
What treatment would I have?
Once you have completed these initial tests, you will be told which study treatment you will receive (HRT or the COC). This will be selected randomly by a computer and you will have an equal chance of being in either of the two groups.HRT can be prescribed as a tablet which is taken once daily, a gel applied to the skin daily or as a skin patch
What are the possible benefits of taking part?
You will be offered recommended treatments for POI whether or not you decide to take part in the study. However, if you choose to take part, the monitoring of your health, including any changes to your bone density, may be increased compared to routine treatment. In addition, you will have access to your study doctor throughout the duration of the study. The information we collect from this study may help us to understand more about the best way to treat women with POI in the future.
What are the possible disadvantages and risks of taking part?
Study treatment:
Both HRT and COC are routine treatments for POI. As with all medications, there is a small risk of side-effects. Common side effects of both HRT and COC include headaches, breast pain and irregular bleeding; however, these side effects are not specific to the study and could also occur with standard care. Your doctor or nurse will discuss any possible effects of the potential treatments with you when talking about the options and your preferences. They will check that any treatment will not interact with any other medication you might take. HRT is not necessarily a contraceptive, and the use of non-hormonal contraception is advised.
Bone density measurements:
Bone density is measured using low dose radiation (x-rays). Everyone is exposed to radiation sources every day, for example from the sun. The amount of radiation from a bone density measurement is less than 2 days’ exposure to natural radiation and much lower than that of a standard x-ray. However, you must not have a bone density scan if you are or think you could be pregnant.
Blood samples:
If you are having blood samples taken, this is a standard procedure which is unlikely to cause any problems but can sometimes cause discomfort. There is a risk of bruising, reddening and swelling of the vein, but this normally clears up with no further trouble.
It is up to you whether or not you take part in the study. We will talk to you about the study and answer any questions you may have. If you agree to take part, we will ask you to sign a consent form (this may be provided online or by email). If you decide to take part, you will be free to withdraw at any time, without giving a reason. This would not affect the standard of care you receive.
Who has reviewed the study?
All research in the NHS is reviewed and approved by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and approved by Essex Research Ethics Committee.
How will information about me be used?
Researchers at the Nottingham Clinical Trials Unit (part of the University of Nottingham) will need to use information from you and your medical records for this study. This information will include your initials, NHS number (CHI number if you are living in Scotland), name and contact details. The researchers will use this information to do the research or to check your records to make sure that the research is being done properly.
People who do not need to know who you are will not be able to see your name or contact details, your data will have a code number instead. All information about you will be kept safe and secure.
Once the study has finished, some of the information will be kept so the results can be checked and you can be told what happened in the study (unless you tell us you do not want to know). Reports will be written in a way that no-one can work out that you took part in the study.
Your personal contact details will be available to the Nottingham Clinical Trials Unit (NCTU) so they can contact you during the study and send you the questionnaires. 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 study and study questionnaires whilst you are participating in the study.
You can find out more about how we use your information:
• At www.hra.nhs.uk/information-about-patients/ and www.hra.nhs.uk/patientdataandresearch
• At www.ucl.ac.uk/legal-services/privacy/participants-health-and-care-research-privacy-notice
• At www.nctu.ac.uk/data-protection/data-protection.aspx
By asking one of the research team:
• By sending an email to poise@nottingham.ac.uk
Open Recruiting Centres