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

This study is testing whether an investigational drug called OBE2109, alone and in combination with add-back therapy, can reduce heavy menstrual bleeding associated with uterine fibroids in premenopausal women. In addition, this study will compare OBE2109 with a placebo to see if taking OBE2109 is better than taking a placebo.  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.

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.