Back to Search
Start Over
A randomized, comparative safety study of a prefilled plastic and user-filled paper applicator with candidate microbicide tenofovir 1% gel.
- Source :
-
Sexually transmitted diseases [Sex Transm Dis] 2013 Jun; Vol. 40 (6), pp. 476-81. - Publication Year :
- 2013
-
Abstract
- Background: A bridging study was performed to compare the safety, dose delivery, and acceptability of a prefilled plastic and user-filled paper applicator to assess whether a low-cost, user-filled, paper applicator could serve as a delivery option for tenofovir (TFV) 1% vaginal microbicide gel.<br />Methods: The study used a randomized crossover design with 25 healthy women randomized to begin with the prefilled or user-filled applicator. Within each study arm, participants delivered two 4.0-mL doses of TFV 1% gel vaginally for 7 days, with one dose delivered at the clinic each morning and a second dose delivered at home each evening. To assess the primary objective, applicator safety, colposcopy examinations were performed at 2 time points in each study arm.<br />Results: There were no colposcopic findings or adverse events attributable to either applicator. One case of vulvovaginal candidiasis was considered possibly related to gel use. On average, the user-filled applicator delivered 96% of the target dose, with 85% of doses falling within ± 10% of the average dose volume. Participants found both applicators comparable for ease of use, insertion, and dispensing gel, with 60% of participants preferring the user-filled applicator.<br />Conclusions: This study suggests that both applicators are safe, and most women delivered TFV with the user-filled applicator as directed. Participants found both applicators acceptable, with a slight majority preferring the user-filled applicator. Incorporating a low-cost, user-filled, paper applicator to deliver TFV could help reduce costs and improve access to TFV 1% gel, especially in resource-limited settings heavily impacted by HIV.
- Subjects :
- Adenine administration & dosage
Adenine adverse effects
Administration, Intravaginal
Adolescent
Adult
Anti-HIV Agents administration & dosage
Cross-Over Studies
Drug Delivery Systems instrumentation
Drug Delivery Systems methods
Female
Humans
Middle Aged
Organophosphonates administration & dosage
Paper
Patient Acceptance of Health Care
Plastics
Tenofovir
Treatment Outcome
Vaginal Creams, Foams, and Jellies administration & dosage
Young Adult
Adenine analogs & derivatives
Anti-HIV Agents adverse effects
Drug Delivery Systems adverse effects
HIV Infections prevention & control
Organophosphonates adverse effects
Vaginal Creams, Foams, and Jellies adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1537-4521
- Volume :
- 40
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Sexually transmitted diseases
- Publication Type :
- Academic Journal
- Accession number :
- 23677021
- Full Text :
- https://doi.org/10.1097/OLQ.0b013e3182927ab1