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| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 11, 2008 |
| Last Updated Date | June 2, 2009 |
| Start Date ICMJE | February 2008 |
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
To determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE |
To determine the safety and PK properties of 200 mg and 300 mg of Proellex® taken for seven days by healthy adult female subjects. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] |
| Change History | Complete list of historical versions of study NCT00619385 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Safety and Pharmacokinetic Study of Proellex® |
| Official Title ICMJE | A Safety and Pharmacokinetic Study of 100 mg, 150 mg and 200 mg of Proellex® Taken for Seven Days by Healthy Adult Female Subjects |
| Brief Summary | This is an open-label, single-center, outpatient, unblinded, multi-dose study of the safety and pharmacokinetic properties of Proellex®. Six female subjects will each receive seven daily doses of Proellex® 100 mg, 150 mg and 200 mg in separate, rising doses. Dosing must be accomplished between menstrual periods. The first six women will complete the 100 mg visit schedule before the next six women will begin the 150 mg visit schedule. Blood will be collected at pre-dose, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24 and 36 (Day 7 only) hrs post-dose on Day 1 and Day 7. Subjects will be allowed to leave the clinic between the 12 and 24 hr and the 24 and 36 hr PK blood draws. Subjects will be discharged from the study after a one month follow-up visit. Safety will be assessed throughout the study. |
| Detailed Description | |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Condition ICMJE | Healthy |
| Intervention ICMJE | Drug: Proellex |
| Study Arms / Comparison Groups |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 12 |
| Completion Date | October 2008 |
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female |
| Ages | 18 Years to 34 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00619385 |
| Responsible Party | Andre vanAs, MD, PhD, Repros Therapeutics |
| Study ID Numbers ICMJE | ZP-003 |
| Study Sponsor ICMJE | Repros Therapeutics Inc. |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Repros Therapeutics Inc. |
| Verification Date | June 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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