Join the largest
Join the largest
What is it?
Amphora is a non-hormonal vaginal gel currently undergoing the largest Phase III contraceptive clinical trial to date.
The clinical trial is testing its efficacy of preventing pregnancy, as compared to the leading spermicide Conceptrol® vaginal gel.
Hormone-free and latex-free contraceptive trial
half of women are not satisfied with their current birth control pills
non-invasive contraceptive trial
Study related gynecological care at no cost
Investigational products at no cost
How its used in this study
This study is to determine whether Amphora maintains the woman’s natural vaginal defense when sperm is introduced.
When sperm enters the vaginal canal it lowers the vagina’s natural pH level. This study will determine if Amphora is able to maintain the vagina’s natural acidic pH level and create a hostile environment for sperm.
About the Trial
What to expect
A select group of subjects from each arm of the study will undergo colposcopy (close examination of the cervix) at their initial “admission visit” and at visits following cycles one, three, and seven. A lighted microscope used to magnify cervical tissue (colposcopic) will be used to take photographs during these visits. Subjects participating for 13 cycles will also undergo a colposcopy following cycles 10 and 13. During the examination, the examiner may take small samples of cervical tissue (biopsies). Another specialist, a pathologist, will examine the tissue samples and cells.
Benefits for participation
- Study related gynecological care at no cost to the participant
- Investigational product (Amphora) or Conceptrol at no cost
- What is the purpose of the Amphora clinical trial?
The Amphora clinical trial is testing whether Amphora gel is effective for use in preventing pregnancy. Amphora gel is being compared to a contraceptive gel (Conceptrol®) that has previously been approved by the FDA. Study participants will be randomly assigned to use either Amphora or Conceptrol as their primary contraceptive method throughout the trial.
- How long will my participation in the trial last?
Volunteers are required to participate for a minimum of seven menstrual cycles. Some study participants may be given the option of continuing their participation for a total of 13 cycles. However, you are always free to stop participating in the trial at any time.
- Am I obligated to use the gel after the trial has ended?
No. Once you have completed the required number of cycles for the trial you will discontinue your use of Amphora or Conceptrol as part of the clinical trial.
- Is Amphora safe for topical use?
The Amphora clinical trial is currently evaluating its safety and efficacy as a contraceptive gel.
- How long before intercourse can I use the gel?
The study gel should be inserted before intercourse, and may be inserted a maximum of one hour prior to intercourse.
- What are the possible risks?
Due to the nature of the Amphora clinical trial, the main risk of participating is pregnancy. It is important to understand that pregnancy may occur while participating in the trial. In previous clinical trials, the most common side effect associated with use of the study gel was genital irritation, which was generally reported as "mild" or "moderate."
- Should I tell my doctor I am interested in participating in the Amphora trial?
If you have a primary care physician or a gynecologist, it is recommended that you speak with him or her prior to participating in the trial. If you do not have a doctor, you can speak to a physician from the research center conducting the trial to help you decide if participating in this trial is right for you.
- What if I get pregnant?
Pregnancy is a risk while participating in the Amphora clinical trial. In order to meet FDA requirements, subjects may not use a back-up contraception method for the duration of their participation in the trial. If pregnancy is a concern, it is recommended that you speak to a health care provider regarding your participation in the trial. In order to volunteer for this study, you must be willing to accept the risk of becoming pregnant.
- What if I want to stop using the gel midway through the trial?
If you are unable or unwilling to participate in the trial for the required seven cycles, please contact your research clinic as soon as possible. You are free to stop participating in the Amphora clinical trial at any time, but it is important to discuss this with your study clinician.
- Where is the nearest clinic?
There are 38 participating research clinic sites throughout the U.S. Find a nearest clinic near you.
- Will I be compensated for my participation in the trial?
Participants in the Amphora clinical trial will receive study-related gynecological care and investigational product for use throughout the duration of the trial. Subjects will be reimbursed for travel-and/or child care-related expenses resulting from fulfilling trial visit requirements. Child care or medical care expenses resulting from pregnancy during the trial will not be compensated.
- Does Amphora gel protect against sexually transmitted infections (STIs)?
Amphora gel has not been tested for efficacy in preventing STIs.
- Should I use back-up protection or contraception with the gel?
During the trial, subjects are required to use only the study gel provided to them for trial use by the research clinic prior to intercourse and should not use any other contraceptive method in conjunction with the provided gel.
July 23, 2013Enrollment Completed for Evofem’s 3,200-subject Global Trial of Amphora® Non-hormonal Contraceptive Gel
The global trial compares Amphora to Conceptrol®, the brand name of Nonoxynol-9, and the only spermicidal gel currently approved by the FDA.
March 20, 2011EVOFEM To Start Largest Contraceptive Clinical Trial
Evofem, Inc. will begin the largest global contraceptive clinical trial in April 2011.
December 8, 2009Women's Healthcare Company, EVOFEM, Receives $25 Million Private Equity European Investment
Private healthcare company markets Instead Softcup menstrual protection product and is developing spermicide/microbicide gel, Amphora, which shows promise in protecting women against sexually transmitted diseases including the AIDS virus.
Join the Trial
Locate a Clinic
Please select your state
Locate a clinic near you
Alabama Clinical Therapeutics, LLC Birmingham, Alabama, United States, 35235
Contact Lisa Palmedo
Principal Investigator William Summers, MDlisa.palmedo AT medsearchrx DOT com
Lynn Institute of the Ozarks Little Rock, Arkansas, United States, 72205
Contact Harmony Kerr
Principal Investigator Caroline May, MDhkerr AT lhsi DOT net
Advanced Clinical Research Institute Anaheim, California, United States, 92801
Contact Rosa Quiceno, CRC
P 714-774-7777 x240
Principal Investigator Jesus Hernandez, MDrquiceno AT agmg DOT com
California Family Health Council Los Angeles, California, United States, 90010
Contact Amber Van Kessel, MA
P 510-647-0632 x2205
Principal Investigator Anita Nelson, MDVanKesselA AT cfhc DOT org
California Family and Health Council, Inc., LA Los Angeles, California, United States, 90010
Contact Ron Frezieres
Principal Investigator Deborah Nucatola, MDfrezieresr AT cfhc DOT org
Women's Health Care San Diego, California, United States, 92123
Contact Rovena Reagan, MD
Principal Investigator Rovena Reagan, MDregulatory AT womenwellness DOT net
Planned Parenthood of the Rocky Mountains Denver, Colorado, United States, 80302
Contact Kara C Armstrong, MPH
Principal Investigator Savita Ginde, MDkara.armstrong AT pprm DOT org
Downtown Women's Healthcare Denver, Colorado, United States, 61820
Contact Arthur Waldbaum, MD
Principal Investigator Arthur Waldbaum, MDdrwaldbaum AT md4women DOT com
Stamford Therapeutics Consortium Stamford, Connecticut, United States, 06095
Contact Judy Dalgin
Principal Investigator David M Radin, MDjdalgin AT stctrials DOT com
Meridien Research Bradenton, Florida, United States, 34208
Contact Patti Woods
Contact Linda Fucheck
Principal Investigator Louis Chaykin, MDpwoods AT meridienresearch DOT net
Avail Clinical Reseach DeLand, Florida, United States, 32720
Contact Kelly Clement
Principal Investigator John Hill, MDkclement AT accelclinical DOT com
Miami Research Associates Miami, Florida, United States, 33143
Contact Erin Godbold
P 305-279-0015 x3325
Principal Investigator Robert Feldman, MDegodbold AT miamiresearch DOT com
Segal Institute for Clinical Research North Miami, Florida, United States, 33161
P 305-722-8444 x2356
Principal Investigator Steven Chavoustie, MD
Meridien Research St. Petersburg, Florida, United States, 33709
Contact Dawn Welshans, RN, BSN, CCRC
Principal Investigator Gigi Lefebvre, MDdwelshans AT meridienresearch DOT net
Comprehensive Clinical Trials West Palm Beach, Florida, United States, 33409
Contact Linda Wyatt, RN, MSN, SC
Principal Investigator Robert Ackerman, MDlwyatt AT cctlc DOT net
Soapstone Center for Clinical Research Decatur, Georgia, United States, 30034
Contact Natalie Hinton
Principal Investigator Tyrone Malloy, MDnhinton4sccr AT aol DOT com
Rosemark WomenCare Specialist Idaho Falls, Idaho, United States, 83404
Contact Cheryl D Walker
Principal Investigator Jeffrey Baker, MDdwalker AT rosemark DOT net
Heartland Research Associates, LLC Wichita, Kansas, United States, 67207
Contact Kathy Stoddard, RN, CCRC
Principal Investigator Terry Poling, MDkstoddard AT heartlandresearch DOT com
Blue Grass Clinical Research Louisville, Kentucky, United States, 40291
Contact Karen M Dick, RN, CCRC
Principal Investigator Arthur Donovan, MDbcrkdick AT yahoo DOT com
Johns Hopkins Community Physicians Baltimore, Maryland, United States, 21211
Contact Kathy Brugh
Principal Investigator Lynn Bradleykbrugh1 AT jhmi DOT edu
Eastern Carolina Women's Center New Bern, North Carolina, United States, 28562
Contact Kelly Nichols, LPN, CCRC
P 252-633-3942 x314
Principal Investigator Jeffrey Michelson, MDknichols AT womensctr DOT com
Wake Research Associates Raleigh, North Carolina, United States, 27612
Contact Emilie Dunlap, MBA
Principal Investigator Pouru Bhiwandi, MDedunlap AT wakeresearch DOT com
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire, United States, 03756
Contact Pamela A Dauphinais
Principal Investigator Debra L. Birenbaum, MDPamela.A.Dauphinais AT hitchcock DOT org
Women's Health Research Center Plainsboro, New Jersey, United States, 08536
Contact Monique Carignan
P 609-799-5010 x11
Principal Investigator Scott Eder, MDmonique AT scottedermd DOT com
NYU Medical Center Family Planning New York, New York, United States, 10016
Contact Anna Davis, CRC
Principal Investigator Livia Wan, MDanna.davis AT nyumc DOT org
Columbia University Medical Center, Division of Family Planning New York, New York, United States, 10032
Contact Jillian Bynum, MPH
Principal Investigator Carolyn Westhoff, MDjb3262 AT columbia DOT edu
University of Cincinnati Cincinnati, Ohio, United States, 45267
Contact Rose Maxwell, PhD
Principal Investigator Michael Thomas, MDmaxwelra AT ucmail.uc DOT edu
Planned Parenthood of Northeast Ohio Cleveland, Ohio, United States, 44302
Contact Latina Brooks, CNP, PhD
Principal Investigator Laszlo Sogor, MDL.Brooks AT ppneo DOT org
Oregon Health Sciences University Portland, Oregon, United States, 97239
Contact Rozie Janik
Principal Investigator Jeffrey Jensen, MDjanik AT ohsu DOT edu
Philadelphia Clinical Research Philadelphia, Pennsylvania, United States, 19114
Contact Eugene Andruczyk, DO, MBA
Principal Investigator Eugene Andruczyk, DO, MBAeugene AT phillyresearch DOT com
University of Pennsylvania Medical Center, Reproductive Research Unit Philadelphia, Pennsylvania, United States, 19104
Contact Kelly Timbers
Principal Investigator Kurt Barnhart, MDktimbers AT obgyn.upenn DOT edu
Magee-Womens Hospital Pittsburgh, Pennsylvania, United States, 15213
Contact Dionne M Best
Principal Investigator Beatrice Chen, MDbestdm AT mail.magee DOT edu
Advanced Research Associates Corpus Christi, Texas, United States, 78414
Contact Lisa Roberson
Principal Investigator C. Dale Eubank, MDlisa AT araresearch DOT com
Practice Research Organization Dallas, Texas, United States, 75230
Contact Kristen Dow
Principal Investigator Kathryn Waldrep, MDkdow AT practiceresearch DOT net
UT Southwestern Medical Center - Dept. of OB/GYN Dallas, Texas, United States, 75390
Contact Linda Boykin-Pierce
Principal Investigator Bruce R Carr, MDlinda.boykin-pierce AT UTSouthwestern DOT edu
TMC Life Research, Inc Houston, Texas, United States, 77054
Contact Debbie Goble
P 713-799-1635 x101
Principal Investigator Mark Jacobs, MDdebbiegoble AT tmcliferesearch DOT com
Tidewater Clinical Research Norfolk, Virginia, United States, 23502
Contact April Rusch
P 757-471-3375 x111
Principal Investigator Jeffrey Wentworth, MDtccrusch AT cox DOT net
Contact your clinic
8910 University Center Lane, Suite 120
San Diego, CA
E info [at] evofem [dot] com
For more information on Evofem, Inc. visit Evofem.com