Clinical Trial 37399

Huntington Park, CA 90255


Summary:

Study 37399 Flyer
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Endometriosis is one of the most common gynecological diseases (1). It is defined as the presence of endometrial-like tissue outside the uterus. The condition is predominantly found in women in their reproductive years and disappears spontaneously after menopause. A chronic, inflammatory reaction, induced by the ectopic endometrial cells, results in infertility (2) and a variety of pain symptoms including dysmenorrhea, dyspareunia, chronic pelvic pain, dysuria and dyschezia (3, 4). Often the pain associated with endometriosis is cyclical in nature and reflects the response of the ectopic endometrial- like tissue to cycling reproductive hormones, particularly estrogens. 


Qualified Participants Must:

• Be between 18 and 45 years of age
• Be a woman with surgically, and - if available - histologically confirmed pelvic endometriosis (laparoscopy, laparotomy, vaginal fornix or other biopsy) up to 10 years before and moderate to severe endometriosis- associated pain
• The subject has regular menstrual cycles and the total length of the two screening menstrual cycles should be between 42 to 76 days.
• If of childbearing potential, the subject agrees to use one of the following birth control methods during the entire treatment period of the study:

  1. Sexual abstinence
  2. Partner with a vasectomy with confirmed azoospermia
  3. Double non-hormonal barrier contraception such as condom or diaphragm each combined with spermicide

• If of non-childbearing potential, the subject must have had tubal ligation sterilization at least two months before the screening visit.
• The subject must be able to communicate well with the Investigator and research staff and to comply with the requirements of the study protocol.


Qualified Participants May Receive:

- Patient travel reimbursement $110.00 per visit

- All medication, supplies, procedures, and visits with the doctor will be free for all qualified particpants

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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.