MedTrace Logo

Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel

NCT01306331 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3389

Last updated 2022-07-12

Study results available
· View outcomes & findings →

Summary

This is a research study of a new experimental vaginal gel that helps in vaginal pH regulation and results in immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen. This vaginal gel is called Phexxi™ (previously known as Amphora) and was compared to a commercially available spermicide called Conceptrol®, which contains nonoxynol 9; commonly abbreviated as N-9. Conceptrol® can help prevent pregnancy. This study objective was to determine if this product prevents pregnancy when inserted into the vagina before intercourse.

Conditions

  • Contraception

Interventions

DRUG

Conceptrol

• Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

DRUG

Amphora

• Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • Evofem Inc.

    lead INDUSTRY

Principal Investigators

  • Kelly Culwell, MD · Evofem Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States
  • Russia

Study Locations

More Related Trials

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 NCT01306331 on ClinicalTrials.gov