Autopsy report · NCT00683917
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Cause of deathFunding or business, also safety
“Repros stopped the study for safety and FDA put the study on hold for safety.”
Life of this trial
- Ran for about 1 year 3 months before it stopped.
- 10 participants enrolled.
- Results were posted on the registry 5 years after it ended.
Vital statistics
- Status
- Terminated
- Phase
- Phase 2
- Sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry
- Conditions
- Uterine Fibroids
- Interventions
- Proellex 25 mg; Proellex 50 mg; Lupron Depot
- Participants
- 10
- Sites
- 4
- Countries
- Mexico, United States
Trials that died the same way
- Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection
“The study was stopped due to safety concerns” - Stroke With Transfusions Changing to Hydroxyurea
“The study has been stopped due to safety and futility concerns.” - Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
“The study stopped due to marketing approval by the FDA.” - Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
“Study stopped due to safety reasons.” - A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
“FDA requested us to stop the study”
Look deeper
- The official registry record (the source of truth)
- Record history: every change the sponsor made
- Open it in the database
Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.