Clinical Research Program

Uterine Fibroid Studies

Uterine Fibroid Study with a 3.5 year commitment

Sponsor: AbbVie

Study Description

The purpose of this study is to determine the safety of elagolix and how elagolix works when compared to placebo in reducing heavy menstrual bleeding, the major symptom of uterine fibroids. Subjects will be randomly assigned to receive elagolix in combination with add-back therapy (estradiol/norethindrone acetate) and some subjects will be randomly assigned to take placebo. Elagolix (or ABT-620) is a new oral medication that blocks the release of hormones from the pituitary gland (a tiny organ near your brain behind your eyes). Elagolix is called a GnRH antagonist. It is being developed for the treatment of the symptoms of uterine fibroids. Elagolix inhibits (blocks) the secretion of hormones called gonadotropins from cells in the pituitary gland. As a result, elagolix reduces the production of the sex hormone estrogen by the ovaries in women. The level of estrogen decrease is dependent on the dose of elagolix. Because elagolix can reduce the estrogen below the normal level, it is being tested for the treatment of the symptoms of uterine fibroids, a condition that is hormone-dependent. To date, more than 3700 women, including healthy women and patients with endometriosis and uterine fibroids, have received at least one dose of elagolix.

Purpose of the study:

The purpose of this study is to determine the safety of elagolix and how elagolix works when compared to placebo in reducing heavy menstrual bleeding, the major symptom of uterine fibroids. Subjects will be randomly assigned to receive elagolix in combination with add-back therapy (estradiol/norethindrone acetate) and some subjects will be randomly assigned to take placebo.

Eligibility

You may qualify to participate if you:

  • Are 18 to 50 years of age
  • Must suffer from heavy menstrual bleeding due to uterine fibroids

Commitment:

Study has a commitment of 53 months with 15-17 office visits

Compensation:

Over $2000 if all study visits completed

Uterine Fibroid Study with a 1.5 Year commitment

Sponsor: Chiltern

Study Description

Uterine fibroids (myoma) are harmless (benign), hormone-sensitive, smooth muscle tumors of the uterus. They are the most common tumor of the female reproductive tract in premenopausal women and are usually not noticeable. Uterine fibroids affect approximately 4 out of 10 women between the ages of 35 and 55. At the age of 50 years, nearly 7 out of 10 white women and more than 8 out of 10 black women will have had at least one fibroid. The exact cause of uterine fibroids is not completely understood; however, the sex hormones estrogen and progesterone play an important role in fibroid growth. Fibroids can cause heavy menstrual bleeding, abdominal pressure, abdominal pain, increased urinary frequency, and infertility. Anemia (low iron levels) can result from the heavy bleeding, and many affected women experience reduced well-being. Today, uterine fibroids are usually treated by surgery; however, depending on the extent of surgery, this may cause infertility. Another option is hormonal treatment with so-called Gonadotropin-Releasing Hormone (GnRH) agonists, which cause an important decrease of female sex hormones and thus deprive the uterine fibroids of a growth stimulator. Their use is relatively limited because of side effects, including the bone thinning (bone demineralization). Because of this, GnRH agonists are usually given only temporarily before uterine fibroid surgery. OBE2109 is a new oral drug that is being developed as a possible treatment for women with heavy menstrual bleeding associated with uterine myoma and women with endometriosisassociated pelvic pain. OBE2109 reduces the production of sex hormones such as luteinizing hormone and estradiol. Contrary to GnRH-agonists, the level of hormone reduction is dependent on the dose of OBE2109. OBE2109 has been tested in healthy women and women with endometriosis. To date, 42 women have received a single dose, and 187 women have received repeat doses of OBE2109. Some of the women with endometriosis-related pain also had uterine fibroids and OBE2109 appeared to reduce the bleeding. So far, the most frequent side effects of OBE2109 have been disturbances of the menstrual cycle and hot flushes. It is important that you are not intending to become pregnant and will take precautions not to become pregnant while taking the study drug. Being in this study does not replace your regular medical care. 1.3 What is the purpose of this study? The purpose of this study is to test whether the experimental drug OBE2109, alone and in combination with so-called “add-back therapy,” is safe and can reduce heavy menstrual bleeding associated with uterine fibroids in premenopausal women. What is add-back therapy? GnRH agonists significantly reduce the level of the female hormone estradiol, which may lead to unpleasant side effects such as hot flushes and bone thinning. Add-back therapy – as its name mentions – partially adds back the female sex hormones (estrogen and/or progestin). They are routinely used in postmenopausal women for relief of symptoms occurring during menopause and to prevent the development of fragile bones (osteoporosis). For the same reason, they are frequently used to manage the side effects of GnRH agonists, as they improve the wellbeing of subjects and thus help subjects to adhere to their drug regimen. As described above, the use of a GnRH-Antagonist like OBE2109 will lower the female hormone estradiol in a dose-dependent manner, which can lead to hot flushes and possibly bone thinning. Add-back therapy, when taken together with OBE2109, can help to manage these side effects.

Purpose of the Study

Research study to test whether an investigational drug that targets specific female hormones could help women with heavy bleeding due to fibroids.

Eligibility

You may qualify to participate if you:
  • Are 18 or older
  • Must suffer from heavy menstrual bleeding due to uterine fibroids
  • Are not planning on becoming pregnant in the next two years

Commitment

This study has a commitment duration of 85 weeks with 13 in-clinic study visits.

Compensation

If you qualify and decide to participate, you may receive up to $2,050 if all study visits are completed.