Tell us what do you think about our website?

Trial Logo

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?

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.
placeholder

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.

placeholder


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?

CONTACT US

Where can I take part?

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
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
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
South Tyneside and Sunderland NHS Foundation Trust

Key people:

Investigator:

  • Dr Madhavi Gudipati

Address:

Sunderland Royal Hospital
Kayll Road
SR4 7TP

Study news

Recruitment

71/400

Trial sites

Latest addition to sites:

South Tyneside and Sunderland NHS Foundation Trust
Surrey and Sussex Healthcare NHS Trust
South Tyneside and Sunderland NHS Foundation Trust
Chelsea and Westminster Hospital NHS Foundation Trust

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.

You can find out more information about Regal here:

Download documents:

REGAL trial protocol (6)
Participant Information Leaflet (4)

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.