CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 860 enrolled
Drug / intervention
EVO100 +1 moredrug
Likely dose
EVO100 5 g applied vaginally up to 1 hour prior to coitusAI-extracted
Key inclusion· 7
  • ✓Female aged 18–45 years
  • ✓Documented CT or GC infection within 16 weeks prior to enrollment
  • ✓Negative CT and GC NAAT tests at baseline, OR positive tests with completion of standard-of-care treatment
  • ✓Regular vaginal sexual intercourse with male partner (≥3 times/month) and anticipates continuing during study
Key exclusion· 9
  • ✕Pregnant, actively trying to become pregnant, or breastfeeding
  • ✕Total hysterectomy (uterus and cervix removed)
  • ✕Treatment with CT/GC antibiotics (azithromycin, erythromycin, tetracycline, minocycline, doxycycline, levofloxacin, ofloxacin, ceftriaxone, cefixime) within 14 days prior to enrollment
  • ✕Signs/symptoms indicating persistence of CT/GC infection, new interval infection, or failure to complete prescribed treatment after positive screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03107377
NCT03107377Phase 3Completed
CompareCT.gov

Phase 2B Double-blind Placebo-controlled Efficacy Trial of EVO100 (Previously Known as Amphora ® Gel) for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection

Evofem Inc.·interventional·Posted Apr 11, 2017·Updated Aug 12, 2020

In Brief

A Phase 3 clinical trial evaluating EVO100 and Placebo for Chlamydia Trachomatis Infection. Completed, enrolled 860 participants across 50 sites.

Detailed Summary

Phase 2B double-blind placebo-controlled efficacy trial of EVO100 (previously known as Amphora ® Gel) for the prevention of acquisition of urogenital Chlamydia trachomatis infection

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChlamydia Trachomatis Infection
CountriesUnited States
CollaboratorsClinical Research Management, Inc.

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 11, 2017
Enrollment StartNov 3, 2017
Primary CompletionAug 22, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.2 years ago

Interventions

EVO100drug

5 g dose applied up to 1 hour prior to coitus

Placebodrug

5 g dose applied up to 1 hour prior to coitus