Ignite Creation Date:
2025-12-17 @ 8:05 PM
Ignite Modification Date:
2025-12-24 @ 9:16 AM
Study NCT ID:
NCT00787618
Status:
TERMINATED
Last Update Posted:
2014-08-25
First Post:
2008-11-06
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
Sponsor:
Repros Therapeutics Inc.
Organization:
Study Overview
Official Title:
A Single-Dose, Open-Label, Parallel Group Study To Evaluate The Pharmacokinetics And Safety Profile Of PROELLEX® (CDB-4124) In Female Subjects With Various Stages Of Impaired Renal Function And In Healthy Female Volunteers
Status:
TERMINATED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Increased LFTs
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PK and safety profile of Proellex® in females with various stages of impaired renal function
Detailed Description:
The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: