Hormone therapy for premature ovarian insufficiency
Research type
Research Study
Full title
Hormone therapy for premature ovarian insufficiency: randomised trial and long-term evaluation
IRAS ID
279224
Contact name
Melanie Davies
Contact email
Sponsor organisation
University College London
Eudract number
2020-002589-15
ISRCTN Number
ISRCTN91141124
Duration of Study in the UK
9 years, 0 months, 0 days
Research summary
When menopause occurs in women under the age of 40 it is called Premature Ovarian Insufficiency (POI). The cause is often unknown but may be due to genetic conditions, immune disorders, cancer treatments, or surgery involving the ovaries. The main symptom is absent or very irregular periods. Many women get other menopause symptoms, such as hot flushes and sweats, loss of libido, painful intercourse, mood changes and fatigue. The ability to get pregnant naturally is greatly reduced.
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). Both have advantages and disadvantages and healthcare professionals are uncertain which is the best for relief of symptoms and also for the long-term risks of POI and the POISE trial aims to find this out.
480 women will be recruited from throughout the UK, they must be aged over 18 and under 40, have a diagnosis of POI. Participants will complete questionnaires about their symptoms and have a bone density measurement before being randomly allocated to take either HRT or the COC.Women will be asked about their symptoms after 3,6 and 12 months and then annually to 5 years, using questionnaires. They will also be asked about the impact POI has on their sexual activity and their working life. Bone density measurements will be repeated at 1,2 and 5 years and selected women will also be asked to provide blood samples to look at bone and heart health in more detail.
Information on participants, including diagnosis of cancer and fractures, will be collected via information routinely recorded by the NHS.
REC name
East of England - Essex Research Ethics Committee
REC reference
21/EE/0116
Date of REC Opinion
9 Jul 2021
REC opinion
Further Information Favourable Opinion