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Therapeutic Areas: Obstetrics/Gynecology
Disease Category: Endometriosis

Trial Information

Endometriosis Pain Study

If you are female suffering from pelvic pain because of your endometriosis, you might be interested in participating in a clinical study to evaluate an investigational oral pill for the management of pain caused by endometriosis. This study is designed to see how a research compound works compared to placebo (also known as a sugar pill) or leuprorelin (an approved drug) in women with endometriosis and see the effect on pelvic pain associated with endometriosis.

Qualified participants will receive study-related examinations and diagnostic procedures including a Pap smear, laboratory tests, and Bone Density assessments, and the study medication at no cost.

To qualify you must:

• be female 18 to 45 years of age, inclusive  
• have moderate to severe pelvic pain due to endometriosis
• have been laparoscopy diagnosed with endometriosis
• have recurrent or persistent endometriosis symptoms
• agree to use two forms of non-hormonal contraception
• have menstrual cycles occurring every 23-33 days
• have a body mass index (BMI) of 18 to 32 kg/m2, inclusive
• be willing to attend office visits monthly for approximately 8 months
• not currently using GnRH agonist, GnRH antagonist, danazol, DMPA-SC or DMPA-IM
• not currently using hormonal contraception or other hormonal therapy
• not had surgery for endometriosis within the last month
• not have had a hysterectomy or oopherectomy
• not using systemic steroids on a chronic or regular basis within the last 3 months
• not have uterine fibroids ≥3 cm in diameter
• have pelvic pain from something other than endometriosis (e.g. uterine fibroids) 
• not have been pregnant within the last 6 months
• not currently pregnant or currently breast feeding
• not have an unstable medical condition or chronic disease

Research Site
Located in:
Sofia
Bulgaria
Phone: +359 885 120201
EMail: many777@abv.bg

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