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Phase 2B/3 Double-blinded Placebo-controlled

NCT03107377 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 860

Last updated 2020-08-12

Study results available
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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

Conditions

  • Chlamydia Trachomatis Infection

Interventions

DRUG

EVO100

5 g dose applied up to 1 hour prior to coitus

DRUG

Placebo

5 g dose applied up to 1 hour prior to coitus

Sponsors & Collaborators

  • Clinical Research Management, Inc.

    collaborator INDUSTRY

  • Evofem Inc.

    lead INDUSTRY

Principal Investigators

  • Kelly Culwell, MD · Evofem Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2019-08-22
Completion
2019-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03107377 on ClinicalTrials.gov