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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Damini
Mistry
+44 (0) 115 8231624
poise@nottingham.ac.uk
Prof
Jane
Daniels
+44 (0)115 82 31619
jane.daniels@nottingham.ac.uk
Dr
Melanie
Davies
+44 (0)7939 312402
melanie.davies14@nhs.net
More information about this study, what is involved and how to take part can be found on the study website.
Premature ovarian insufficiency
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
When menopause occurs in women under the age of 40, it is termed Premature Ovarian Insufficiency (POI). 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 hormone replacement therapy (HRT) or combined oral contraceptive pill (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 the study is to find out what is the best treatment for women with POI in the short and long term.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 03/01/2024:
1. Diagnosis of POI (based on NICE guidelines) or with an established diagnosis of POI (e.g. Turner Syndrome, surgical menopause)
2. Will be aged older than 18 and less than 40 years at randomisation
3. Not intending to become pregnant within 12 months
4. Not taken any HRT, COC or testosterone treatment for the last 4 weeks or willing to stop HRT/COC/testosterone treatment for a minimum period of 4 weeks prior to randomisation
5. Must provide written/electronic inf
You may not be able to take part if:
Current exclusion criteria as of 03/01/2024:1. Contraindications to HRT or COC2. Taking other drugs affecting BMD e.g. bisphosphonates and long-term use of systemic corticosteroids (dietary supplements e.g. Vitamin D, calcium and short course of corticosteroids are permitted)3. Receiving estrogens for puberty induction4. Participation in a clinical research study (currently or in the last 3 months) involving testosterone treatments or novel HRT formulations
Previous exclusion criteria:1. Contraindications to HRT or COC2. Taking other drugs affecting BMD e.g. bisphosphonates and long-term use of systemic corticosteroids (dietary supplements e.g. Vitamin D, calcium and short course of corticosteroids are permitted) 3. Receiving sex steroid hormones for puberty induction4. Participation in a clinical research study (currently or in the last 3 months) involving testosterone treatments or novel HRT formulations
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Damini
Mistry
+44 (0) 115 8231624
poise@nottingham.ac.uk
Prof
Jane
Daniels
+44 (0)115 82 31619
jane.daniels@nottingham.ac.uk
Dr
Melanie
Davies
+44 (0)7939 312402
melanie.davies14@nhs.net
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University College London and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR128757; National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 46123
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
