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Contact Information:

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.

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Be Part of Research - Trial Details - What is the most effective hormone treatment for women with premature ovarian insufficiency (POI), in both the short and long-term?

What is the most effective hormone treatment for women with premature ovarian insufficiency (POI), in both the short and long-term?

Medical Conditions

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:

01 Jul 2022 30 Jun 2025

All participants will attend one clinic visit at baseline. During this visit eligibility will be checked and consent will be obtained. Baseline data will be recorded including height, weight, blood pressure and a DEXA bone density measurement (if not already done within last 6 months). Participants will also complete 3 questionnaires; about their quality of life, work productivity and sexual function. Participants will be randomised to one of two treatment groups:
Group A: COC – Women randomised to receive treatment with COC will be prescribed 30µg ethinyloestradiol with 150µg levonorgestrel (Microgynon 30 or equivalent) as an extended regimen; the suggested regimen is 63 days with 7 days hormone-free interval.
Group B: HRT - Women randomised to receive treatment with HRT will be prescribed a continuous preparation with a daily dose of oestradiol of 2mg orally, or a 50µg patch, or 1.5mg of gel.

As is normal in standard practice women with a uterus will also be prescribed progestogen, taken cyclically or continuously.

3 and 6 month follow-up: Participants will attend a routine POI follow-up clinic where their clinician will conduct a clinical review, elicit patient satisfaction with treatment, any adverse effects and conduct routine observations of weight and blood pressure. Participants will be asked to complete 3 questionnaires to assess quality of life, sexual function and work productivity.

1 and 2 year follow-up: Participants will attend a routine POI follow-up clinic where their clinician will conduct a clinical review and conduct routine observations of weight and blood pressure. The participant will undergo a DEXA bone density measurement. Participants will also be asked to complete 3 questionnaires to assess quality of life, sexual function and work productivity.

3 and 4 years follow-up: Participants will attend a routine POI follow-up clinic where their clinician will conduct a clinical review and conduct routine observations of weight and blood pressure. Participants will be asked to complete 3 questionnaires to assess quality of life, sexual function and work productivity.

5 year follow-up: Participants will attend a routine POI follow-up clinic where their clinician will conduct a clinical review and conduct routine observations of weight and blood pressure. The participant will undergo a DEXA bone density measurement. Participants will be asked to complete 3 questionnaires to assess quality of life, sexual function and work productivity.

A small sub-set of women from 3 sites will be invited to provide additional blood samples which will be analysed for bone and cardiovascular biomarkers through the duration of the study.


Women diagnosed with POI who are not intending to become pregnant within the next 12 months.

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.

  • Salisbury District Hospital
    Salisbury District Hospital Odstock Road
    Salisbury
    SP2 8BJ
  • University Hospitals Birmingham NHS Foundation Trust
    Queen Elizabeth Hospital Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus
    Nottingham University Hospital Derby Road
    Nottingham
    NG7 2UH
  • NHS Lothian
    2 - 4 Waterloo Place
    Edinburgh
    EH1 3EG
  • East Lancashire Hospitals NHS Trust
    Royal Blackburn Hospital Haslingden Road
    Blackburn
    BB2 3HH
  • Northern General Hospital
    Sheffield Teaching Hospitals NHS Foundation Trust Herries Road Sheffield South Yorkshire
    Sheffield
    S5 7AU
  • University Hospitals Bristol and Weston NHS Foundation Trust
    Trust Headquarters Marlborough Street
    Bristol
    BS1 3NU
  • Addenbrookes
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • St George's at Kings College Hospital
    Denmark Hill
    London
    SE5 9RS
  • Norfolk & Norwich University Hospital
    Colney Lane Colney
    Norwich
    NR4 7UY
  • Oxford University Hospitals
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU
  • Royal Derby Hospital
    University Hospitals Of Derby And Burton Nhs Foundation Trust Uttoxeter Road
    Derby
    DE22 3NE
  • Guys Hospital
    Guys Hospital Great Maze Pond
    London
    SE1 9RT
  • The Christie Clinic
    550 Wilmslow Road
    Manchester
    M20 4BX
  • South Tyneside and Sunderland NHS Foundation Trust
    Sunderland Royal Hospital Kayll Road
    Sunderland
    SR4 7TP
  • Chelsea and Westminster Hospital
    369 Fulham Road
    London
    SW10 9NH
  • Liverpool Women’s Hospital
    Liverpool Women's NHS Foundation Trust Crown Street
    Liverpool
    L8 7SS
  • NHS Grampian
    Summerfield House 2 Day Road
    Aberdeen
    AB15 6RE
  • University College London Hospital
    University College London Hospitals NHS Foundation Trust Department of Womens Health 250 Euston Road
    London
    NW1 2PG
  • Birmingham Womens Hospital
    Metchley Park Road
    Birmingham
    B15 2TG
  • Imperial College Healthcare NHS Trust
    Nihr Imperial Clinical Research Fac Hammersmith Hospital Du Cane Road
    London
    W12 0HS

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.
Benefits: Information collected from this study may help us to understand more about the best way to treat women with POI in the future.
The monitoring of health, including any changes to bone density may be increased in women taking part compared to those receiving routine treatment.
Risks: Study Treatment: Both HRT and COC are routine treatments for POI but as with all medications, there is a small risk of side-effects.
Bone density measurements: Bone density is measured using low dose radiation (at a much lower level than that of a standard x-ray).
Blood samples: For women having blood samples taken there is a risk of bruising, reddening and swelling of the vein.

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.




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Read full details for Trial ID: ISRCTN91141124

Or CPMS 46123

Last updated 03 January 2024

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