Clinical Research Program

Endometriosis Studies

Endometriosis Study with 21 Month Commitment

Sponsor: Obseva

Study Description

The purpose of this study is to assess the safety and efficacy of different doses of linzagolix alone and in combination with so-called ‘add-back therapy’ compared to placebo (an inactive substance) in women with moderate to severe pain associated with endometriosis. Endometriosis is a hormone-dependent condition in which tissue that normally grows inside the uterus grows outside the uterus. It is one of the most common gynecological diseases. The condition is predominantly found in women in their reproductive years and disappears spontaneously after menopause.  Linzagolix is an experimental drug which is not approved by health authorities such as the US Food and Drug Administration (FDA) for the treatment of moderate to severe pain associated with endometriosis. Linzagolix is a new oral drug, a Gonadotropin-Releasing Hormone (GnRH) antagonist. It has been shown to significantly reduce pain associated with endometriosis in women with endometriosis at once daily doses between 50 and 200 mg with a good safety and tolerability profile. Linzagolix reduces the production of sex hormones such as luteinizing hormone and estradiol. The level of hormone reduction is dependent on the dose of linzagolix. About 450 women will take part in this study at a number of different locations in the US and Canada.

Purpose of the Study

Research Study currently evaluating an oral investigational medication to see if it may reduce moderate to severe endometriosis-associated pain.

Eligibility

You may qualify to participate if you:

  • Are premenopausal, 18-49 years old
  • Has regular menstrual cycles
  • Have had a surgical diagnosis of endometriosis within the past 10-12 years
  • Have moderate to severe pain due to endometriosis during most recent menses and while off menses
  • Are not pregnant or actively trying to get pregnant
  • Do not have osteoporosis or any bone disease

Commitment

This study has a commitment duration of up to 21 months with 16 visits.

Compensation

If you qualify and decide to participate, you may receive up to $2,050.00 if all scheduled visits are completed.

Contact Information

To learn more or see if you qualify, call 804-661-5938