What is Regal?

Endometriosis is a common condition which affects one in ten women from puberty to menopause. It occurs when cells similar to those lining the womb grow outside it, generally within the pelvis. These cells behave like the cells lining the womb, causing internal bleeding at the time of periods, scarring and pain.

Endometriosis is diagnosed by laparoscopy (keyhole surgery) which identifies areas of endometriosis which can then be destroyed or removed. However, surgery rarely provides lasting relief and pain can return in up to half of treated women within five years. To reduce the chance of regrowth of endometriosis and recurrence of pain, women who are not trying to get pregnant are offered the combined oral contraceptive pill or other contraceptives containing hormones called progestogens.

Despite this, about one in three women will require more operations to treat endometriosis that has come back.

Endometriosis depends on the female hormone oestrogen (produced by the ovaries) for growth. Removing the ovaries (often along with the womb) therefore provides the best chance of pain relief and least chance of more operations but is not an option for many premenopausal with endometriosis.

A less invasive way of shrinking endometriosis is to use a drug called Gonadotrophin Releasing hormone analogue (GnRHa) which temporarily stops the ovaries from producing oestrogen. While very effective in terms of reducing pain, this treatment has only been used for up to a year because of side effects such as hot flushes and night sweats and concerns about osteoporosis (thinning of the bones). Recent research has shown that adding small doses of hormone replacement therapy (HRT) in women on GNRHa reduces the risk of side effects and osteoporosis whilst controlling the pain.

REGAL trial is comparing long-term GnRHa with added HRT to further keyhole surgery for treatment of endometriosis in women who experience recurrence of pain after surgery but wish to preserve their fertility.

Can I take part?

You may be eligible to take part in REGAL if:

•     you are female and aged between 21-49 years old
•     you have recurrent pain following laparoscopic treatment for endometriosis
•     you wish to avoid removal of your ovaries and a hysterectomy
•     your doctor considers you suitable for both study arms (Gonadotrophin Releasing hormone analogue (GnRHa with HRT versus further laparoscopic surgery)

Please see ‘Where can I take part?’ to check if your local hospital is participating.

If you would like to know more about REGAL, including information about taking part, please contact the study office at the University of Aberdeen on 01224 438196 or email regal@abdn.ac.uk

If you are interested in taking part, or have any questions?

NHS Grampian

Key people:

Investigator:

Dr Lucky Saraswat

Address:

NHS Grampian
Obstetrics and Gynaecology
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN

NHS Lothian

Key people:

Investigator:

Dr Lucy Whitaker

Address:

NHS Lothian
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA

Oxford University Hospitals NHS Foundation Trust

Key people:

Investigator:

Prof Christian Becker

Address:

Oxford University Hospitals NHS Foundation Trust
OSPREA-Gynae Research Team
Nuffield Dept. of Women's and Reproductive Health
Level 3, Women's Centre, John Radcliffe Hospital
OX3 9DU

University Hospital Southampton NHS Foundation Trust

Key people:

Investigator:

Mr Dimitrios Miligkos

Address:

Reproductive Health Research Team
Princess Anne Hospital
Coxford Road
Southampton
S016 5YA

Cardiff and Vale UHB

Key people:

Investigator:

Mr Lutfi Shamsuddin

Address:

Directorate of Obstetrics & Gynaecology
University Hospital of Wales
Heath Park
Cardiff
CF14 4XW

East Lancashire Hospitals NHS Trust

Key people:

Investigator:

Mr Mohamed Abdel-Aty

Address:

Women and Children's Health Research Team
Area 7, Level 1, Burnley General Teaching Hospital
Casterton Avenue
Burnley
BB10 2PQ

University Hospitals of Leicester NHS Trust

Key people:

Investigator:

Miss Neelam Potdar

Address:

Gynaecology Department
Leicester Royal Infirmary
Infirmary Square,
Leicester
LE1 5WW

University College London Hospitals NHS Foundation Trust

Key people:

Investigator:

Mr Arvind Vashisht

Address:

Gynaecology Diagnostic and Treatment Unit
Lower Ground Floor, EGA Wing
UCLH, 235 Euston Road
London
NW1 2BU

East and North Hertfordshire NHS Trust

Key people:

Investigator:

Mr Chou Phay Lim

Address:

Lister Hospital
Coreys Mill Lane
Stevenage
Hertfordshire
SG1 4AB

North Bristol NHS Trust

Key people:

Investigator:

Miss Jessica Preshaw

Address:

Women and Children's Research
The Chilterns
Southmead Hospital
Bristol
BS10 5NB

Chelsea and Westminster Hospital NHS Foundation Trust

Key people:

Investigator:

Mr Amer Raza

Address:

Obstetrics and Gynaecology
Chelsea and Westminster Hospital
Fulham Road
Chelsea
SW10 9NH

South Tyneside and Sunderland NHS Foundation Trust

Key people:

Investigator:

Dr Madhavi Gudipati

Address:

Reproductive Health and childbirth
South Tyneside Hospital
Harton Lane
South Shields
NE34 0PL

Royal Cornwall Hospitals NHS Trust

Key people:

Investigator:

Mr Thomas Smith-Walker

Address:

Midwifery Research Team
Room F37b
The Knowledge Spa
Royal Cornwall Hospital, Truro, Cornwall
TR1 3HD

Surrey and Sussex Healthcare NHS Trust

Key people:

Investigator:

Miss Helen Nicks

Address:

AD 86, Trust Headquarters
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH

University Hospitals Sussex NHS Foundation Trust

Key people:

Investigator:

Dr Rebecca Mallick

Address:

Downsmere Research Office
Princess Royal Hospital
Lewes Road
Haywards Heath
RH16 4EX

South Tyneside and Sunderland NHS Foundation Trust

Key people:

Investigator:

Dr Madhavi Gudipati

Address:

Sunderland Royal Hospital
Kayll Road
SR4 7TP

NHS Greater Glasgow and Clyde

Key people:

Investigator:

Miss Felicity Watson

Address:

Glasgow Clinical Research Facility
5th Floor, Institute of Neurological Sciences
Queen Elizabeth University Hospital
1345 Govan Road, Glasgow
G51 4TF

Worcestershire Acute Hospitals NHS Trust

Key people:

Investigator:

Miss Donna Ghosh

Address:

Department of Gynaecology & Obstetrics
Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD

NHS Ayrshire & Arran

Key people:

Investigator:

Dr Inna Sokolova

Address:

Consultant Obstetrician & Gynaecologist
University Hospital Crosshouse,
KILMARNOCK
KA2 0BE

Study news

Recruitment

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Trial sites

Latest addition to sites:

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Key facts about the study and documents

What is this study about?

If you are eligible and wish to participate in REGAL and your hospital is a recruiting site, you will receive further information from your local research team.

To take part you will be asked to sign the study consent form and complete a questionnaire about your pain and quality of life. After this, the local research nurse will randomise you into the study i.e. you will be allocated (at random) to receive one of the treatments below:

• Gonadotrophin Releasing hormone analogue (GnRHa) with HRT
• Further laparoscopic surgery

We will regularly follow your progress for 24 months.

We will send you the study questionnaire through the post (or email if you prefer) at 6, 12, 18 and 24 months from the date you entered the study. The questionnaires are returned to the study office in a prepaid envelope which we provide.

Introducing the REGAL Research Study

The A-Z of the REGAL Research Study

Participating in the REGAL Research Study

You can find out more information about Regal here:

Download documents:

Participant Information Leaflet (5)

REGAL trial protocol (8)

Key contacts

Click on cards to find out more

Organisation

Funding acknowledgement

The project is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (reference NIHR127280) and run by the University of Aberdeen, in conjunction with NHS Grampian. The views expressed are those of the author(s) and do not necessarily those of the NHS, the NIHR or the Department of Health & Social Care.

General Data Protection Regulation (GDPR)

Participant Information

University of Aberdeen/NHS Grampian is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Aberdeen/NHS Grampian will keep identifiable information about you at least 25 years after the study has finished.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information here : https://www.abdn.ac.uk/about/privacy/research-participants-938.php or by contacting the Data Protection office at dpa@abdn.ac.uk

Tell us what do you think about our website?

WELCOME TO THE Regal STUDY

Recurrence of Endometriosis: A randomised controlled trial of clinical and cost-effectiveness of Gonadotrophin Releasing Hormone Analogues with add-back hormone replacement therapy versus repeat Laparoscopic surgery

What is Regal?

Can I take part?

If you are interested in taking part, or have any questions?

Where can I take part?

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Study news

Recruitment

Trial sites

Latest addition to sites:

Key facts about the study and documents

What is this study about?

You can find out more information about Regal here:

Download documents:

Key contacts

Click on cards to find out more

Chief Investigator Dr Lucky Saraswat

Trial Office REGAL

Organisation

General Data Protection Regulation (GDPR)