1. Is capable of understanding and giving written informed consent. 
   
2. Is a menstruating female between the ages of 18 to 45 years.
   
3. Has a regular menstrual cycle length of between 21 to 35 days.
   
4. Is in good health (with the exception of endometriosis), as determined by a physical examination, vital signs, medical history, and clinical laboratory tests.
   
5. Has mild or moderate pelvic endometriosis that has been surgically-confirmed within no less than 3 months and no more than 36 months prior to Visit 1, as established by surgical exploration (i.e., laparoscopically-proven pelvic endometriosis).
   
6. Has symptoms (including pain) consistent with surgically-confirmed pelvic endometriosis and a diagnosis that eliminates other possible causes, including inflammatory bowel disease (IBD) and chronic urogenital infections.
   
7. Has a negative pregnancy test and, if sexually active, agrees that partner(s) will use a condom without a spermicide for birth control throughout the study.
   
8. Is physically able and willing to apply study drug as directed.
   

1. Is pregnant or lactating, or has a history of pregnancy within 6 months prior to Visit 1. (Patients will be advised not to become pregnant for at least 30 days after the last dose of study drug.).
   
2. Has active signs or symptoms secondary to concomitant disease which may mask other pelvic signs or symptoms secondary to endometriosis (e.g., ovarian cysts greater than 3 cm).
   
3. Is currently on Depo-Provera® or oral contraceptives or has used oral contraceptives within 2 spontaneous menstrual cycles prior to Visit 1.
   
4. Has a history of thyroid problems, unless the patient is stabilized on medication(s) for at least 2 spontaneous menstrual cycles prior to Visit 1.
   
5. Has a known history of malignancy of the breast or genital organs or current findings that are suspicious of malignancy of the breast or genital organs. 
   
6. Has undiagnosed abnormal vaginal, uterine or genital bleeding within the 12 months prior to Visit 1 or ongoing abnormal vaginal, uterine or genital bleeding within 2 spontaneous menstrual cycles prior to Visit 1.
   
7. Has had major surgery that was not related to endometriosis within 6 months prior to Visit 1.
   
8. Has had any medical therapy(ies) or used any over-the-counter (OTC) medication (including herbal remedies; see Appendix III) for the treatment of endometriosis within 30 days prior to Visit 1. Pain medication(s) is an allowed medication. 
   
9. Has a history of or is currently using illicit drugs or alcohol abuse or has a positive urine drug screen.
   
10. Has a positive blood test for HIV antibodies.
    
11. Has participated in a clinical investigation within 30 days prior to Visit 1.
    
12. Has had a hysterectomy or is planning to have a hysterectomy during the study period.
    
13. Uses intravaginal products (e.g., tampons) or devices (i.e., diaphragm, intrauterine device [IUD]) during the study period.
    

Chicago Area
Institute for the Study and Treatment of Endometriosis
2425 West 22nd Street, Suite 102
Oakbrook, IL 60523
www.oakbrookinfertility.com
630-954-0054
Contact: Michele

Cleveland Area
Green Road Obstetrics and Gynecology
1611 South Green Road, Suite 216
South Euclid, OH 44121
www.endometriosisUSA.com
800-891-5285
Contact: Ina