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

NCT01306331 | Completed Phase 3 Results DMC

• 1 other identifier: AMP001
• Study Type: interventional
• Target: 3,389
• Locations: 2 countries
• Sites: 52

Brief 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

Outcome Measures

Primary Outcomes (1)

• 6-Month (183 Days) Cumulative Pregnancy Percentage

  The primary endpoint was the evaluation of contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the MITT population by treatment group

  183 days

Secondary Outcomes (1)

• 6-Month (183 Days) Cumulative Pregnancy Percentage for Subjects With Perfect Use

  183 days

Study Arms (2)

Conceptrol

ACTIVE COMPARATOR

100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel

Drug: Conceptrol

Amphora

EXPERIMENTAL

Citric acid USP, potassium bitartrate USP, and L-lactic acid USP

Drug: Amphora

Interventions

Conceptrol DRUG

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

Conceptrol

Amphora DRUG

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

Amphora

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be healthy women, who are sexually active, at risk for pregnancy, and desiring contraception.
• Be within the age range of 18 through 35 (inclusive) at enrollment if not in the subset of women with an age of 36-45 at enrollment (age subset at select sites).
• Be at low-risk for both human immunodeficiency virus (HIV) and sexually transmitted disease (STD) infection and currently have a single sex partner (≥ 4 months) who is also at low-risk for both HIV and STD infection.
• Have a negative urine pregnancy test prior to enrollment.
• Have normal cyclic menses with a usual length of 21 to 40 days over the last two cycles or at least one spontaneous, normal menstrual cycle (two menses) since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy.
• Be willing to accept a risk of pregnancy.
• Be willing to engage in at least two acts of heterosexual vaginal intercourse per cycle.
• Be willing to be randomized to either study treatment.
• Be willing to use the study product as the only method of contraception over the course of the study (with the exception of emergency contraception (EC)), when indicated).
• Be capable of using the study product properly and agree to observe all study directions and requirements.
• Be willing to keep a daily diary to record coital information, product use information, information about the use of other vaginal products, and sign and symptom data for both the subject and her partner.
• Agree not to participate in any other clinical trials during the course of the study with the exception of enrolling in the Amphora™ gel extension study.
• Be willing to give written informed consent to participate in the trial.

You may not qualify if:

• Have a history of allergy or sensitivity to spermicides or products containing N-9 (nonoxynol-9).
• Have had three or more urinary tract infections (UTIs) in the past year.
• Have a UTI by urine culture, symptomatic yeast vaginitis, or symptomatic bacterial vaginosis diagnosed by wet mount unless treated and proof of cure is documented.
• Have a history of any recurrent vaginal infections/disorders (either less than or equal to four times in the past year or less than or equal to three times in the previous six months).
• Be pregnant, have a suspected pregnancy, or desire to become pregnant during the course of the study.
• Have a history of infertility or of conditions that may lead to infertility, without subsequent intrauterine pregnancy.
• Have any contraindications to pregnancy (medical condition) or chronic use of medications for which significant evidence of fetal risk exists.
• Have had more than one sexual partner in the last four months.
• Have shared injection drug needles in the past unless has a negative HIV test at least six weeks since last use.
• Have or have been suspected to have HIV infection.
• Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within three months prior to screening.
• Have three or more outbreaks of HSV within the last year.
• Have evidence of Chlamydia trachomatis or Neisseria gonorrhoeae unless she and her partner complete treatment and proof of cure is documented.
• Have been diagnosed with any other STDs in the six months prior to the Randomization Visit (with the exception of human papillomavirus (HPV), trichomonas, gonorrhea, adn Chlamydia).
• Be lactating or breastfeeding.

Sponsors & Collaborators

• Evofem Inc.: lead
• Premier Research: collaborator

Study Sites (52)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72205, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

California Family Health Council, Inc.

Berkeley, California, 94710, United States

Location

California Family and Health Council, Inc., LA

Los Angeles, California, 90010, United States

Location

California Family Health Council

Los Angeles, California, 90010, United States

Location

Women's Health Care

San Diego, California, 92123, United States

Location

Downtown Women's Healthcare

Denver, Colorado, 61820, United States

Location

Planned Parenthood of the Rocky Mountains

Denver, Colorado, 80302, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06095, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

Avail Clinical Reseach

DeLand, Florida, 32720, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Comprehensive Clinical Trials

West Palm Beach, Florida, 33409, United States

Location

Soapstone Center for Clinical Research

Decatur, Georgia, 30034, United States

Location

Rosemark WomenCare Specialist

Idaho Falls, Idaho, 83404, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Johns Hopkins Community Physicians

Baltimore, Maryland, 21211, United States

Location

Impact Clinical Trials

Las Vegas, Nevada, 89106, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

NYU Medical Center Family Planning

New York, New York, 10016, United States

Location

Columbia University Medical Center, Division of Family Planning

New York, New York, 10032, United States

Location

Eastern Carolina Women's Center

New Bern, North Carolina, 28562, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Planned Parenthood of Northeast Ohio

Cleveland, Ohio, 44302, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Medical Center, Reproductive Research Unit

Philadelphia, Pennsylvania, 19104, United States

Location

Philadelphia Clinical Research

Philadelphia, Pennsylvania, 19114, United States

Location

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

Practice Research Organization

Dallas, Texas, 75230, United States

Location

UT Southwestern Medical Center - Dept. of OB/GYN

Dallas, Texas, 75390, United States

Location

TMC Life Research, Inc

Houston, Texas, 77054, United States

Location

MacArthur OB/GYN

Irving, Texas, 75062, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Women's Clinical Research Center

Seattle, Washington, 98105, United States

Location

Kazan State Medical University

Kazan', Republic Tatarstan, 420012, Russia

Location

State Budgetary Institution fo Rostov region "Parinatal Center"

Rostov-on-Don, Rostov Oblast, 344068, Russia

Location

Moscow Regional Research Institute of Obstetrics and Gynecology

Moscow, 101000, Russia

Location

City Clinical Hospital #13

Moscow, 115280, Russia

Location

City Clinical Hospital #31

Moscow, 119415, Russia

Location

First Moscow State Medical University named after IM Sechenov

Moscow, 119991, Russia

Location

Maternity Hospital #17

Saint Petersburg, 195257, Russia

Location

Medical Center "Prime-Rose"LLC

Saint Petersburg, 197374, Russia

Location

The DO Ott Research Institute of Obstetrics and Gynecology

Saint Petersburg, 199034, Russia

Location

Hospital OrCli

Saint Petersburg, 199178, Russia

Location

Ural Scientific Research Institution of Maternity and Child Protection

Yekaterinburg, 620028, Russia

Location

MeSH Terms

Interventions

Nonoxynol

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Clinical Operations
• Organization: Evofem

clinicaloperations@evofem.com

858-550-1900

Study Officials

• Kelly Culwell, MD

  Evofem Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 1, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 12, 2022
• Results First Posted: July 30, 2020

Record last verified: 2022-06

Locations

US (41); RU (11)