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Clinical Trial 13846

San Antonio, TX 78209

Study Summary:

ICON Development Solutions is conducting a research study of an investigational medication in Healthy female volunteers, ages 18 – 47 with uterine fibroids.

The purpose of the study is to determine the safety of an investigational drug when given vaginally on healthy women with uterine fibroids. The study drug is being developed for the treatment of uterine fibroids and endometriosis.

The following procedures /samples will be performed or obtained during the study: Vital signs, physical and pelvic examinations, pap smears, vaginal ultrasounds, MRI’s (an imaging test to create images of the body), colposcopies (a procedure to closely examine the cervix, vagina and vulva), blood and urine samples.

Qualified Participants Must:

• Be a healthy female between the ages of 18 and 47 with uterine fibroids
• Have a BMI between 18 and 39 kg/m2
• Not smoke or use any tobacco products while confined in the unit
• Have regular periods
• Not have received any investigational medications in the past 30 days prior to screening
• Discontinue hormonal contraceptives and use a condom for the duration of the study Not to become pregnant
• Limit alcohol consumption to no more than 2 drinks per week and avoid alcohol consumption within 48 hours of each visit
• Not to attempt to become pregnant
• Complete a daily subject diary
• Insert vaginal suppositories
• Only use sanitary napkins for the duration of the study (no tampons)

Qualified Participants May Receive:

You may be compensated up to $1300.00 for time and travel and an additional $750 for perfect attendance (available after confirmation of study drug compliance).

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.