Clinical Trial 38641

Sacramento, CA 95821


Summary:

Endometriosis is a common chronic condition that can cause pain in the lower part of the stomach (pelvis) during menstrual period and at other times and pain during sexual intercourse. Northern California Research is conduction a study for premenopausal women with endometriosis. 

Northern California Research is conducting a study that is seeking FDA approval for a new medication to asses if it is effective and can treat endometriosis-associated pain in premenopausal women. The study medication will be given with or without low-dose estradiol and norethindrone is in treating your condition, endometriosis-associated pain. Estradiol is a form of estrogen and norethindrone is a form of progesterone. Both estrogen and progesterone are FDA approved hormones. The study is double-blind, meaning that neither you nor your study doctor/staff will know which study drug you will receive. You will be randomized into one out of 3 different study medication groups, you have an equal chance of being in any of the 3 study groups. 

In order to participate you must have a diagnosis of endometriosis with surgical visualization of endometriosis via laparoscopy or laparotomy performed within the past 10 years. 


Qualified Participants Must:

• Be a premenopausal female aged 18 to 50 years old (inclusive)
• Have had 3 consecutive regular menstrual cycles (ie, 21 to 35 days in duration) prior to first office visit
• Must have a diagnosis of endometriosis with surgical visualization of endometriosis via laparoscopy or laparotomy performed within the past 10 years


Qualified Participants May Receive:

 All trial-related visits, tests, and medications will be provided to you at no cost.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.