The Wave3 clinical trial is testing Amphora's safety and efficacy of preventing pregnancy, as compared to the leading spermicide Conceptrol®
Join the largest
hormone-free, non-invasive
contraceptive trial
Join the largest
hormone-free, non-invasive
contraceptive trial
Participants will receive:
- Study related gynecological care at no cost
- Investigational product (Amphora) or Conceptrol® at no cost
Amphora
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
More than
half of women are not satisfied with their current birth control pills
Largest
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
Overview
Amphora is now undergoing the largest contraceptive clinical trial to date. The clinical trial is testing Amphora's efficacy in preventing pregnancy compared to spermicidal vaginal gel, Conceptrol®.
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
FAQs
- 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.
News
Contact
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Locate a Clinic
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Locate a clinic near you
Alabama Clinical Therapeutics, LLC Birmingham, Alabama, United States, 35235
Contact Lisa Palmedo
P 205-833-2228
Principal Investigator William Summers, MD
lisa.palmedo AT medsearchrx DOT com
Lynn Institute of the Ozarks Little Rock, Arkansas, United States, 72205
Contact Harmony Kerr
P 501-975-2001
Principal Investigator Caroline May, MD
hkerr 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, MD
rquiceno 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, MD
VanKesselA AT cfhc DOT org California Family and Health Council, Inc., LA Los Angeles, California, United States, 90010
Contact Ron Frezieres
P 213-386-5614
Principal Investigator Deborah Nucatola, MD
frezieresr AT cfhc DOT org Women's Health Care San Diego, California, United States, 92123
Contact Rovena Reagan, MD
P 858-505-8672
Principal Investigator Rovena Reagan, MD
regulatory AT womenwellness DOT net Planned Parenthood of the Rocky Mountains Denver, Colorado, United States, 80302
Contact Kara C Armstrong, MPH
P 303-813-7646
Principal Investigator Savita Ginde, MD
kara.armstrong AT pprm DOT org Downtown Women's Healthcare Denver, Colorado, United States, 61820
Contact Arthur Waldbaum, MD
P 303-298-0222
Principal Investigator Arthur Waldbaum, MD
drwaldbaum AT md4women DOT com Stamford Therapeutics Consortium Stamford, Connecticut, United States, 06095
Contact Judy Dalgin
P 203-325-8529
Principal Investigator David M Radin, MD
jdalgin AT stctrials DOT com Meridien Research Bradenton, Florida, United States, 34208
Contact Patti Woods
P 941-756-8680
Contact Linda Fucheck
P 813-877-8839
Principal Investigator Louis Chaykin, MD
pwoods AT meridienresearch DOT net Avail Clinical Reseach DeLand, Florida, United States, 32720
Contact Kelly Clement
P 386-785-2411
Principal Investigator John Hill, MD
kclement AT accelclinical DOT com Miami Research Associates Miami, Florida, United States, 33143
Contact Erin Godbold
P 305-279-0015 x3325
Principal Investigator Robert Feldman, MD
egodbold 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
P 727-347-8839
Principal Investigator Gigi Lefebvre, MD
dwelshans AT meridienresearch DOT net Comprehensive Clinical Trials West Palm Beach, Florida, United States, 33409
Contact Linda Wyatt, RN, MSN, SC
P 561-473-3177
Principal Investigator Robert Ackerman, MD
lwyatt AT cctlc DOT net Soapstone Center for Clinical Research Decatur, Georgia, United States, 30034
Contact Natalie Hinton
P 404-534-9982
Principal Investigator Tyrone Malloy, MD
nhinton4sccr AT aol DOT com Rosemark WomenCare Specialist Idaho Falls, Idaho, United States, 83404
Contact Cheryl D Walker
P 208-557-2991
Principal Investigator Jeffrey Baker, MD
dwalker AT rosemark DOT net Heartland Research Associates, LLC Wichita, Kansas, United States, 67207
Contact Kathy Stoddard, RN, CCRC
P 316-689-6635
Principal Investigator Terry Poling, MD
kstoddard AT heartlandresearch DOT com Blue Grass Clinical Research Louisville, Kentucky, United States, 40291
Contact Karen M Dick, RN, CCRC
P 502-231-1982
Principal Investigator Arthur Donovan, MD
bcrkdick AT yahoo DOT com Johns Hopkins Community Physicians Baltimore, Maryland, United States, 21211
Contact Kathy Brugh
P 410-338-3060
Principal Investigator Lynn Bradley
kbrugh1 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, MD
knichols AT womensctr DOT com Wake Research Associates Raleigh, North Carolina, United States, 27612
Contact Emilie Dunlap, MBA
P 919-781-2514
Principal Investigator Pouru Bhiwandi, MD
edunlap AT wakeresearch DOT com Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire, United States, 03756
Contact Pamela A Dauphinais
P 603-653-3968
Principal Investigator Debra L. Birenbaum, MD
Pamela.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, MD
monique AT scottedermd DOT com NYU Medical Center Family Planning New York, New York, United States, 10016
Contact Anna Davis, CRC
P 212-263-6253
Principal Investigator Livia Wan, MD
anna.davis AT nyumc DOT org Columbia University Medical Center, Division of Family Planning New York, New York, United States, 10032
Contact Jillian Bynum, MPH
P 212-305-8031
Principal Investigator Carolyn Westhoff, MD
jb3262 AT columbia DOT edu University of Cincinnati Cincinnati, Ohio, United States, 45267
Contact Rose Maxwell, PhD
P 513-584-4509
Principal Investigator Michael Thomas, MD
maxwelra AT ucmail.uc DOT edu Planned Parenthood of Northeast Ohio Cleveland, Ohio, United States, 44302
Contact Latina Brooks, CNP, PhD
P 216-661-0400
Principal Investigator Laszlo Sogor, MD
L.Brooks AT ppneo DOT org Oregon Health Sciences University Portland, Oregon, United States, 97239
Contact Rozie Janik
P 503-494-0585
Principal Investigator Jeffrey Jensen, MD
janik AT ohsu DOT edu Philadelphia Clinical Research Philadelphia, Pennsylvania, United States, 19114
Contact Eugene Andruczyk, DO, MBA
P 215-676-6696
Principal Investigator Eugene Andruczyk, DO, MBA
eugene AT phillyresearch DOT com University of Pennsylvania Medical Center, Reproductive Research Unit Philadelphia, Pennsylvania, United States, 19104
Contact Kelly Timbers
P 215-662-2974
Principal Investigator Kurt Barnhart, MD
ktimbers AT obgyn.upenn DOT edu Magee-Womens Hospital Pittsburgh, Pennsylvania, United States, 15213
Contact Dionne M Best
P 412-641-1403
Principal Investigator Beatrice Chen, MD
bestdm AT mail.magee DOT edu Advanced Research Associates Corpus Christi, Texas, United States, 78414
Contact Lisa Roberson
P 361-906-9178
Principal Investigator C. Dale Eubank, MD
lisa AT araresearch DOT com Practice Research Organization Dallas, Texas, United States, 75230
Contact Kristen Dow
Principal Investigator Kathryn Waldrep, MD
kdow AT practiceresearch DOT net UT Southwestern Medical Center - Dept. of OB/GYN Dallas, Texas, United States, 75390
Contact Linda Boykin-Pierce
P 214-648-2318
Principal Investigator Bruce R Carr, MD
linda.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, MD
debbiegoble AT tmcliferesearch DOT com Tidewater Clinical Research Norfolk, Virginia, United States, 23502
Contact April Rusch
P 757-471-3375 x111
Principal Investigator Jeffrey Wentworth, MD
tccrusch AT cox DOT net Contact your clinic
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