Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00787618
Eligibility Criteria:
Inclusion Criteria:
* Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
* Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred
* Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
* Subject with renal impairment must have evidence of stable disease
* If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
* Negative urine pregnancy test at screening visit
* Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control
* Healthy subject must have no significant abnormal findings at the screening physical examination
* Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)
* Additional inclusion criteria may apply
Exclusion Criteria:
* Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
* Subject with clinically significant abnormal liver function
* Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study
* An acute illness within five (5) days of study medication administration
* Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
* Additional exclusion criteria may apply
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
48 Years
Study:
NCT00787618
Study Brief:
Protocol Section:
NCT00787618