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.
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 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.
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.