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ContraceptionPhase 3NCT03243305

AMP002 Phase III Contraceptive Study

A Phase 3 study testing AMPHORA in people with Contraception, run by Evofem Inc. at 87 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-arm, open-label, Phase III study in approximately 100 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Contraception
What is being tested?
AMPHORA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,384 participants
Where
87 sitesUnited States
Study dates
24 Jul 2017to 29 Nov 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • To enroll in the clinical study, potential subjects must:
  • Be healthy women, who are sexually active, at risk of pregnancy, and desiring contraception.
  • Be within the age range of 18 to 35 years old (inclusive) at enrollment.
  • In the opinion of the Investigator, be at low risk for both human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) based on review of high-risk behaviors and exposures according to the Centers for Disease Control STI Guideline.
  • At the time of enrollment, have a single male sex partner for ≥3 months.
  • Have a negative urine pregnancy test at enrollment.
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  • Have normal, cyclic menses with a usual length of 21 to 35 days over the last two cycles or at least two consecutive spontaneous menses (21 to 35 days in length) since delivery, abortion, or after discontinuing hormonal contraception or hormonal therapy prior to the date of consent. In addition:
  • If the subject recently discontinued breastfeeding, she must have demonstrated return to regular cycling and have had at least three consecutive, spontaneous menses post-lactation prior to the date of consent.
  • If the subject received prior administration of injectable contraceptives (e.g., depot-medroxyprogesterone acetate [DMPA], Depo Provera), there must be at least 10 months since the last injection and the subject must have had at least two consecutive, spontaneous menses prior to the date of consent.
  • If a contraceptive implant was recently removed, the subject must have had at least two consecutive, spontaneous menses prior to the date of consent.
  • If an intrauterine device (IUD) was recently removed, the subject must have had at least one spontaneous menses following removal and prior to the date of consent.
  • Be willing to engage in at least three acts of heterosexual vaginal intercourse per cycle.
  • Be willing to use the study drug as the only method of contraception over the course of the study (with the exception of emergency contraception [EC] in the event a subject engages in vaginal intercourse but believes that the study drug was not used properly or she is at risk for pregnancy for any other reason).
  • Be capable of using the study drug properly and agree to comply with all study directions and requirements, including retaining the wrappers and returning them to the clinical site at the next study visit.
  • Be willing to keep a daily electronic diary (eDiary) to record coital information, study drug use information, use of concomitant medications including other vaginal products and other contraceptives, menses, and sign and symptom data for the subject or as reported to her by her partner.
  • Agree not to participate in any other clinical studies during the course of the study.
  • Be capable and willing to give written informed consent to participate in the study.

Who cannot join

  • To enroll in the clinical study, potential subjects must not:
  • Have had three or more urinary tract infections (UTIs) in the past year from the date of consent.
  • Have a UTI by urine culture, chlamydia, gonorrhea, or symptomatic yeast vaginitis or symptomatic bacterial vaginosis (BV) diagnosed by wet mount, or trichomoniasis, unless treated and proof of cure is documented within the screening period.
  • Have used vaginal or systemic antibiotics or antifungals within 14 days prior to enrollment, with the exception of vaginal or systemic antibiotics or antifungals completed for the treatment of a UTI, BV, or yeast vaginitis diagnosed at screening within seven days of the Enrollment Visit.
  • Have a history of any recurrent vaginal infections/disorders (either greater than or equal to four times in the past year or greater than or equal to three times in the previous six months from the date of consent).
  • Be pregnant, have a suspected pregnancy, or desire to become pregnant during the course of the study.
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  • Have a history of diagnosed infertility or of conditions that may lead to infertility, without subsequent non-assisted reproductive technology intrauterine pregnancy.
  • Have any maternal contraindications to pregnancy (medical condition) or chronic use of medications for which significant evidence of fetal risk exists.
  • Have known or screen test positive for HIV infection.
  • Have three or more outbreaks of genital herpes simplex virus (HSV) within the last year from the date of consent or be receiving suppressive therapy.
  • Have visible genital condylomata (warts).
  • Be lactating or breastfeeding.
  • Have any clinically significant abnormal finding on physical examination including pelvic examination or baseline laboratory assessments which in the opinion of the Investigator, precludes study participation.
  • Have clinically significant signs of vaginal or cervical irritation on pelvic examination.
  • Be planning to have any (e.g., diagnostic or therapeutic) vaginal or cervical procedures during the period of the study.
  • Have an abnormal Papanicolaou test (Pap test) based on the following criteria:
  • Pap test in the past 12 months from the date of screening with atypical squamous cells of undetermined significance (ASC-US) unless at least one of the following criteria is met: i. Less than 21 years of age. ii. A repeat Pap test at least six months later was normal. iii. Reflex human papillomavirus (HPV) testing was performed and was negative for high-risk HPV.
  • A colposcopy (with or without biopsy) found no evidence of dysplasia requiring treatment or treatment was performed and follow up at least six months after the treatment showed no evidence of disease.
  • Pap test in the past 12 months from the date of screening with low grade squamous intraepithelial lesion (LSIL) unless at least one of the following criteria is met: i. Less than 21 years of age. ii. A colposcopy (with or without biopsy) found no evidence of dysplasia requiring treatment or treatment was performed and follow up at least six months after the treatment showed no evidence of disease.
  • Pap test in the past 12 months from the date of screening with atypical squamous cells in which high grade squamous intraepithelial lesion cannot be excluded (ASC-H), atypical glandular cells, high grade squamous intraepithelial lesion (HSIL), or ≥30 years old who are cytology negative and HPV 16- or HPV 18-positive unless colposcopy and/or treatment was performed and follow up at least six months after the colposcopy and/or treatment showed no evidence of disease.
  • Pap test in the past 12 months with malignant cells.
  • Consume (on average) more than three drinks of an alcoholic beverage per day.
  • In the opinion of the Investigator, have a history of substance abuse in the last 12 months.
  • Have taken an investigational drug or used an investigational device within the past 30 days from the date of consent.
  • In the opinion of the Investigator, have issues or concerns that may compromise the safety of the subject, impact the subject's compliance with the protocol requirements, or confound the reliability of the data acquired.
  • Be an Evofem, PAREXEL, or clinical site employee regardless of direct involvement in research activities, or their close relative.

Trial locations and contacts

87 sites in 1 country.

87 sites in 1 country

United States87 sites

  • Bosque Women's Care 117

    Albuquerque, New Mexico, 87109

  • Anaheim Clinical Trials, LLC 135

    Anaheim, California, 92801

  • Agile Clinical Research Trials 161

    Atlanta, Georgia, 30328

  • Premier Family Physicians 102

    Austin, Texas, 78735

  • American Health Network, Inc. - Avon 144

    Avon, Indiana, 46123

  • Pioneer Research Solutions, Inc. 164

    Beaumont, Texas, 77702

  • Essential Access Health 159

    Berkeley, California, 94710

  • Elite Clinical Trials 105

    Blackfoot, Idaho, 83221

  • Hope Clinical Research, LLC 163

    Canoga Park, California, 91303

  • Family Medicine Associates of Texas 106

    Carrollton, Texas, 75010

  • PMG Research of Cary 134

    Cary, North Carolina, 27518

  • PI-Coor Clinical Research, LLC 153

    Centreville, Virginia, 20121

  • Women's Health Practice 132

    Champaign, Illinois, 61820

  • East Valley Family Physicians 137

    Chandler, Arizona, 85224

  • Medical Research South 126

    Charleston, South Carolina, 29407

  • Radient Research, Inc. 152

    Cincinnati, Ohio, 45236

  • Flordia Clinical Research Group, LLC 130

    Clearwater, Florida, 33759

  • Elite Research Network - Rapid Medical Research, Inc. 171

    Cleveland, Ohio, 44122

  • Lynn Institute of the Rockies 172

    Colorado Springs, Colorado, 80920

  • Aventiv 128

    Columbus, Ohio, 43213

  • Complete Healthcare for Women 151

    Columbus, Ohio, 43231

  • Clinical Trials Management, LLC 131

    Covington, Louisiana, 70433

  • Practice Research Organization 115

    Dallas, Texas, 75230

  • Downtown Women's Healthcare 109

    Denver, Colorado, 80209

  • Physician's Research Options, LLC 178

    Draper, Utah, 84020

  • Clinical Physiology Associates 160

    Fort Myers, Florida, 33912

  • Women's Health Advantage 162

    Fort Wayne, Indiana, 46825

  • Brownstone Clinical Trials 191

    Fort Worth, Texas, 76104

  • American Health Network, Inc. - Franklin 146

    Franklin, Indiana, 46131

  • Frederick OB/GYN 189

    Frederick, Maryland, 21702

  • AGA Clinical Trials 108

    Hialeah, Florida, 33012

  • Health Care Family Rehab and Research Center 193

    Hialeah, Florida, 33012

  • The Community Research of South Florida 167

    Hialeah, Florida, 33016

  • Vital Pharma Research, Inc. 123

    Hialeah, Florida, 33016

  • Centex Studies, Inc. 182

    Houston, Texas, 77058

  • Southeast Texas Family Planning & Cancer Screening 121

    Houston, Texas, 77074

  • Texas Center for Drug Development. Inc. 150

    Houston, Texas, 77081

  • UF Health Woman's Specialist - Emerson 194

    Jacksonville, Florida, 32207

  • Health Awareness, Inc. 129

    Jupiter, Florida, 33458

  • The University of Tennessee Medical Center 188

    Knoxville, Tennessee, 37920

  • Grossmont Center for Clinical Research 119

    La Mesa, California, 91942

  • Altus Research 142

    Lake Worth, Florida, 33461

  • Office of Edmond Pack, MD 192

    Las Vegas, Nevada, 89106

  • Clinical Research Center of Nevada 136

    Las Vegas, Nevada, 89123

  • R. Garn Mabey, Jr., MD, Chartered 116

    Las Vegas, Nevada, 89128

  • Arkansas Primary Care Clinic 205

    Little Rock, Arkansas, 72204

  • Optimal Research, LLC 107

    Melbourne, Florida, 32934

  • Mesa Obstetricians & Gynecologists 184

    Mesa, Arizona, 85209

  • ActivMed Practices & Research, Inc. 133

    Methuen, Massachusetts, 01844

  • South Florida Research Center, Inc. 165

    Miami, Florida, 33135

  • Advanced Pharma CR, LLC 156

    Miami, Florida, 33147

  • AppleMed Research Group, LLC 154

    Miami, Florida, 33155

  • New Horizon Research 155

    Miami, Florida, 33155

  • Vista Health Research 166

    Miami, Florida, 33176

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 36608

  • Unified Women's Clinical Research 125

    Morehead City, North Carolina, 28557

  • American Health Network, Inc. - Muncie 145

    Muncie, Indiana, 47304

  • Eastern Carolina Women's Center 103

    New Bern, North Carolina, 28562

  • Coastal Connecticut Research, LLC 141

    New London, Connecticut, 06320

  • Clinical Research Associates of Tidewater 148

    Norfolk, Virginia, 23507

  • Heuermd Research, Inc. 140

    Orlando, Florida, 32819

  • Health Care Family Rehab and Research 190

    Pembroke Pines, Florida, 33024

  • Clinical Research of Philadelphia 186

    Philadelphia, Pennsylvania, 19114

  • Family Practice Specialists Ltd 170

    Phoenix, Arizona, 85018

  • Precision Trials AZ, LLC 176

    Phoenix, Arizona, 85032

  • North Texas Family Medicine 104

    Plano, Texas, 75093

  • Lyndhurst Clinical Research 110

    Raleigh, North Carolina, 27607

  • Atlanta North Gynecology, PC 120

    Roswell, Georgia, 30075

  • Northern California Research 179

    Sacramento, California, 95821

  • Saginaw Valley Medical Research Group, LLC 124

    Saginaw, Michigan, 48604

  • Wasatch Clinical Research 183

    Salt Lake City, Utah, 84107

  • Neera Bhatia, MD OB/GYN 180

    San Antonio, Texas, 78212

  • Progressive Clinical Research 187

    San Antonio, Texas, 78213

  • Medical Center for Clinical Research 101

    San Diego, California, 92108

  • Optimal Research, LLC 149

    San Diego, California, 92108

  • Women's Health Care 122

    San Diego, California, 92123

  • Physician Care Clinical Research 158

    Sarasota, Florida, 34239

  • Radiant Research, Inc. 111

    Scottsdale, Arizona, 85251

  • Seattle Women's: Health, Research, Gynecology 113

    Seattle, Washington, 98105

  • Planned Parenthood of the St. Louis Regions 169

    St Louis, Missouri, 63108

  • Harbor - UCLA LABIOMED 143

    Torrance, California, 90502

  • Visions Clinical Research Tucson 138

    Tucson, Arizona, 85712

  • Eclipse Clinical Research 185

    Tucson, Arizona, 85745

  • Empire Clinical Research 175

    Upland, California, 91786

  • Visions Clinical Research 168

    Wellington, Florida, 33414

  • Upstate Clinical Research Associates 114

    Williamsville, New York, 14221

  • Southeastern Research Center 139

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: AMPOWER A Single-arm, Phase III, Open Label, Multi-center, Study in Women Aged 18-35 Years of the Contraceptive Efficacy and Safety of Phexxi™ (Previously Referred to as AMPHORA®) Contraceptive Vaginal Gel

This is a single-arm, open-label, Phase III study in approximately 100 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.

Read the detailed description

Through assessments including pelvic examination, laboratory procedures, and medical and gynecological history, subjects will be screened for eligibility in order to enroll approximately 1349 subjects into the study. After a screening period of up to 60 days, enrolled women will receive study drug. Each woman will participate in the study until after she has completed treatment during seven study cycles. Women who have individual cycles that do not meet the criteria for an evaluable cycle will not have those cycles replaced by subsequent cycles in order to provide a total of seven evaluable cycles.

Conditions
Contraception
Being tested
AMPHORA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMPHORADrug

    non-hormonal contraceptive vaginal gel

Study groups in NCT03243305
Study groupRoleWhat they receive
InterventionalExperimentalThis is a single-arm, open-label, Phase III study of AMPHORA , a non-hormonal contraceptive, at approximately 100 sites in the United States (US) over seven cycles of use in women aged 18 to 35 years who are at risk of pregnancy.
Receives: Drug: AMPHORA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy

    To evaluate the contraceptive efficacy of Amphora over 7-cycle of use

    Measured: 10 months

Secondary outcomes (1)

  1. Number of Subjects With Adverse Events (AE)

    Incidence of AE to evaluate safety

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start24 Jul 2017
  3. Primary completion29 Nov 2018
  4. Study completion29 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Single Arm, unblinded
Masking
None (open label)
Enrolment
1,384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03243305
Sponsor's protocol ID
AMP002
Status last verified
Sep 2020
First submitted
29 Jun 2017
Last updated
17 Sep 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AMPHORA in people with Contraception, run by Evofem Inc. at 87 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03243305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.

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