Autopsy report · NCT02762617

Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring (TDF IVR-002)

“Safety-related”

The sponsor’s own words in the registry.

Life of this trial

• Registered 10 months before it started.
• Ran for about 8 months before it stopped.
• 17 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

Marla Keller

Sponsor type

University, hospital or other

Conditions

Healthy; HIV

Interventions

Tenofovir disoproxil fumarate intravaginal ring; Placebo intravaginal ring (IVR)

Participants

17

Sites

2

Countries

Kenya, United States

Trials that died the same way

• A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6)
  “Safety Issues” (81% match in meaning)
• AGN-242428 in the Treatment of Plaque Psoriasis
  “safety reason” (75% match in meaning)
• Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.
  “New Safety Information” (73% match in meaning)
• A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive Epilepsy
  “Safety Review” (71% match in meaning)
• Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
  “For safety concerns” (70% match in meaning)

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.