Indications for: PHEXXI
On-demand method of contraception.
Limitations of Use:
Not effective for preventing pregnancy when administered after intercourse.
The efficacy of Phexxi for the prevention of pregnancy was evaluated in a multi-center, open-label, single-arm clinical trial in the US (AMP002; NCT03243305). The study enrolled females 18–35 years of age with regular menstrual cycles (21–35 days). The median age was 27.8 years.
- Patients agreed to engage in at least 3 acts of heterosexual, vaginal intercourse per cycle.
- Patients self-administered a 5 gram dose of Phexxi intravaginally up to one hour before each episode of intercourse for up to 7 cycles.
- The primary efficacy endpoint was the 7-cycle typical use cumulative pregnancy rate as derived by Kaplan-Meier life-table analysis.
- A total of 101 on-treatment pregnancies occurred in 1183 patients contributing 4769 evaluable natural cycles.
- The 7-cycle cumulative pregnancy rate was 13.7% (95% CI, 10.0%-17.5%), excluding cycles with back-up contraception, cycles <21 days or >35 days in length and cycles in which no intercourse was reported.
- The estimated Pearl Index, calculated based on data from the 7-cycle study, was 27.5 (95% CI, 22.4%-33.5%).
Insert 1 applicatorful vaginally immediately before or up to 1hr before each act of intercourse. Must apply additional dose if more than 1 act of intercourse occurs within 1hr.
Premenarche: not indicated.
History of recurrent urinary tract infection or urinary tract abnormalities: avoid use. Pregnancy.
Vaginal pH regulator.
Avoid contraceptive vaginal rings.
Vulvovaginal effects (burning sensation, pruritus, mycotic infection, discomfort, pain), urinary tract infection, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria; cystitis, pyelonephritis, hypersensitivity reaction.
Generic Drug Availability:
Prefilled single-dose vaginal applicators—12