Publications by authors named "T Jacot"
Objective: To study the role of PGE in regulating plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (tPA) in human primary endometrial endothelial cells (HEECs) from women with normal menstrual bleeding (NMB) and heavy menstrual bleeding (HMB).
Design: In vitro study using endometrial endothelial cells.
Setting: Research laboratory setting.
Objectives: Evaluate the safety of Ovaprene, an investigational nonhormonal vaginal contraceptive designed for monthly use.
Study Design: Open-label, multicenter study enrolling heterosexually-active women with previous permanent contraception who underwent assessments during five menstrual cycles: baseline postcoital test cycle, diaphragm postcoital test cycle, Ovaprene safety cycle, and two Ovaprene postcoital test cycles. Safety outcomes included treatment-emergent adverse events, systemic laboratory findings, pelvic examinations, colposcopies, Nugent scores, determination of community state types of vaginal microbiota, and anti-Escherichia coli activity and inflammatory markers in cervicovaginal fluids.
Article Synopsis
- Many young women globally experience the dual challenges of HIV and unintended pregnancies, highlighting the need for multipurpose prevention technologies.
- A study involving 312 healthy women aged 18-34 randomized participants to use either a tenofovir/levonorgestrel (TFV/LNG), TFV-only, or placebo intravaginal ring to assess safety and effectiveness.
- Results showed that both TFV IVR groups demonstrated significant increases in HIV inhibition in cervicovaginal fluid, with no serious adverse effects linked to the products, indicating their potential as safe prevention methods.
Article Synopsis
- The study investigated the safety and efficacy of a new intravaginal ring (IVR) combining tenofovir (TFV) and levonorgestrel (LNG) for preventing sexually transmitted infections and unintended pregnancies among women.
- 47 women participated, using either the active IVR or a placebo for 90 days, with results showing no serious adverse effects and maintained mucosal health.
- TFV was found to achieve high local concentrations and significantly inhibited HIV replication, although users experienced higher rates of anovulation and some changes in cervical mucus quality.
Background: A relationship between the vaginal microbiota and tenofovir (TFV) concentrations and activity after topical administration has been previously reported.
Objective: CONRAD A15-138 was a randomized, placebo-controlled Phase I study aimed at characterizing the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TFV and levonorgestrel (LNG) administered through a vaginal ring (IVR) for 90 days. Herein, we describe changes from baseline in the vaginal microbiota with IVR use and the impact of the vaginal microbiota on mucosal TFV PK.