Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Repros Therapeutics Inc.
This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.
Age
18–34
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
Must have a negative urine pregnancy test at screening
Able to swallow gelatin capsules
Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
You may not be if
Symptomatic uterine fibroids or endometriosis
Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
