TABLET research and Elagolix research

Mrs Caroline Overton is Primary Investigator for the TABLET trial at University Hospitals Bristol.  Please phone 0117 342 5756 If you would like to be considered to take part.

TABLET research pages on the Birmingham University website

The TABLET trial is a randomised, double-blind, placebo-controlled trial which is looking at the role of thyroid antibodies in miscarriage. There is evidence that thyroid antibodies can influence important pregnancy outcomes such as increasing the risk of miscarriage and delivering a baby prematurely. The TABLET Trial is a national study in which all women trying for a pregnancy under the age of 41 are invited to have a blood test to see if they have thyroid antibodies.

We are particularly interested in seeing whether a drug called Levothyroxine reduces the risk of miscarriage in women who have thyroid antibodies even though their thyroid hormones are in the normal range.

Over 4,500 women who have miscarried will be screened for thyroid peroxidase antibodies in around 20 UK early pregnancy assessment and recurrent miscarriage clinics.  In addition women who are having infertility treatment will be screened.  It is anticipated over 900 will be randomised into the TABLET Trial.

We are keen to recruit as many women as possible so they can be sure that numbers are big enough to make the eventual results reliable.  So if you might be interested in taking part, here’s what you need to know:

Who can take part?

We are recruiting women who:

  • are aged 16 – 40
  • hope to conceive in the next year
  • have had a previous miscarriage or are due to have treatment for infertility
  • do not have known thyroid disease – and are willing to be selected at random to have either the treatment or a placebo, without knowing which they are given.

Endometriosis Pain Clinical Research Study

Mrs Caroline Overton is Primary Investigator for the SOLSTICE trial at University Hospitals Bristol.  Please phone 0117 342 5756 If you would like to be considered to take part.

The SOLSTICE clinical research study is for women who are dealing with endometriosis pain. SOLSTICE is a randomized, placebo-controlled trial to evaluate the safety and effectiveness of Elagolix for moderate to severe endometriosis pain symptoms.

Who can take part?

We are recruiting women who:

  • Are 18 to 49 years old and have not gone through menopause
  • Have been surgically diagnosed with endometriosis in the past 10 years and have moderate to severe endometriosis-associated pain symptoms during your period and at other times in your menstrual cycle
  • Are not taking pain medication to treat a chronic disease other than endometriosis, such as painful bladder syndrome, adenomyosis or fibromyalgia
  • Do not have a history of osteoporosis or another bone disease
  • Are not pregnant or breastfeeding or planning to get pregnant within the next 24 months

There are other requirements to be in the study that we will discuss with you to determine if you are eligible to participate.

What are the study drugs?

The investigational drug is a tablet taken by mouth that reduces the production of estrogen in the ovaries, one of the hormones associated with endometriosis pain. This study will evaluate whether the investigational drug may help manage the painful symptoms associated with endometriosis. The investigational drug is not approved by regulatory agencies as a treatment for endometriosis pain. In this study, the investigational drug will be compared to placebo. Placebo looks the same as investigational drug but has no active drug in it.

If you qualify for and choose to participate in the study, you will be randomly assigned by chance to receive either active investigational drug or placebo for 6 months. You will have a 57 percent chance (4 in 7) of receiving the active investigational drug tablets and a 43 percent chance (3 in 7) of receiving placebo tablets.

How long is the study?

Your participation in the study may last up to approximately 20 months. You will visit the Hospital about 14 times and talk to research staff via telephone about 7 times during the study.  At study visits, you will have tests and procedures to check your health.