Trial Information

Summary: Do you suffer from pain because of your endometriosis?

If you suffer from pain because of your endometriosis, you may qualify to participate in a research study testing the safety and effectiveness of an FDA approved drug given in a different form.

The study is currently taking place only the the United States and participation will last approximately 4 months and will require approximately 6 visits to the doctor's office.

Patient Inclusion Criteria:

• Be a menstruating female betwen the ages of 18-50.
• Have a regular menstrual cycle length of 21-35 days with menstrual bleeding that typically lasts no more than 7 days.
• Have moderate to severe pain associated with your endometriosis (the study doctor can help determine this)
• Have ahd surgical or laparoscopic confirmation of your endometriosis no more than 60 months ago
• Have a negative pregnancy test and agree to use 2 forms of contraception throughout the study (condoms, spermicide, diaphragm, tubal ligation or vasectomy)
• Discontinue the use of any intravaginal devices (intrauterine devices, douches) during the study; use of tampns and diaphragms will be allowed during the study
• Be in good general health
• Be physically able and willing to follow the study schedule and daily diary requirements

Patient Exclusion Criteria:

• Be pregnant or nursing, or have a history of pregnancy within 6 months prior to study entry
• Have ahd a hysterectomy or planning to have a hysterectomy during the study
• Have any condition other than endometriosis that would require chronic use of pain medication
• Have received treatment wtih Danocrine (oral danazol), oral danazol administered intravaginally, depo-provera or Lupron within 6 months prior to study entry
• Have a known history of cancer of the breat or genital organs
• Have had major abdominal surgery that was not related to endometriosis within 6 months prior to study entry.
• Have a history of or an active outbreak of genital or cervical herpes
• Have participated in a clinical investigation within 30 days prior to screening
• Have uncontrolled high blood pressure

If you would like to learn more about participating in this study, please send an e-mail message using the form below.