AMP002 Phase III Contraceptive Study

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: AMPHORA

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.

• Study Type: Interventional
• Enrollment (Actual): 1384
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • Arizona
    • Chandler, Arizona, United States, 85224
      • East Valley Family Physicians 137
    • Mesa, Arizona, United States, 85209
      • Mesa Obstetricians & Gynecologists 184
    • Phoenix, Arizona, United States, 85018
      • Family Practice Specialists Ltd 170
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ, LLC 176
    • Scottsdale, Arizona, United States, 85251
      • Radiant Research, Inc. 111
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research Tucson 138
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research 185
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Arkansas Primary Care Clinic 205
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC 135
    • Berkeley, California, United States, 94710
      • Essential Access Health 159
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, LLC 163
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research 119
    • Sacramento, California, United States, 95821
      • Northern California Research 179
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research 101
    • San Diego, California, United States, 92108
      • Optimal Research, LLC 149
    • San Diego, California, United States, 92123
      • Women's Health Care 122
    • Torrance, California, United States, 90502
      • Harbor - UCLA LABIOMED 143
    • Upland, California, United States, 91786
      • Empire Clinical Research 175
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Lynn Institute of the Rockies 172
    • Denver, Colorado, United States, 80209
      • Downtown Women's Healthcare 109
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Coastal Connecticut Research, LLC 141
  • Florida
    • Clearwater, Florida, United States, 33759
      • Flordia Clinical Research Group, LLC 130
    • Fort Myers, Florida, United States, 33912
      • Clinical Physiology Associates 160
    • Hialeah, Florida, United States, 33012
      • AGA Clinical Trials 108
    • Hialeah, Florida, United States, 33012
      • Health Care Family Rehab and Research Center 193
    • Hialeah, Florida, United States, 33016
      • The Community Research of South Florida 167
    • Hialeah, Florida, United States, 33016
      • Vital Pharma Research, Inc. 123
    • Jacksonville, Florida, United States, 32207
      • UF Health Woman's Specialist - Emerson 194
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc. 129
    • Lake Worth, Florida, United States, 33461
      • Altus Research 142
    • Melbourne, Florida, United States, 32934
      • Optimal Research, LLC 107
    • Miami, Florida, United States, 33135
      • South Florida Research Center, Inc. 165
    • Miami, Florida, United States, 33147
      • Advanced Pharma CR, LLC 156
    • Miami, Florida, United States, 33155
      • AppleMed Research Group, LLC 154
    • Miami, Florida, United States, 33155
      • New Horizon Research 155
    • Miami, Florida, United States, 33176
      • Vista Health Research 166
    • Orlando, Florida, United States, 32819
      • Heuermd Research, Inc. 140
    • Pembroke Pines, Florida, United States, 33024
      • Health Care Family Rehab and Research 190
    • Sarasota, Florida, United States, 34239
      • Physician Care Clinical Research 158
    • Wellington, Florida, United States, 33414
      • Visions Clinical Research 168
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Agile Clinical Research Trials 161
    • Roswell, Georgia, United States, 30075
      • Atlanta North Gynecology, PC 120
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials 105
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Women's Health Practice 132
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network, Inc. - Avon 144
    • Fort Wayne, Indiana, United States, 46825
      • Women's Health Advantage 162
    • Franklin, Indiana, United States, 46131
      • American Health Network, Inc. - Franklin 146
    • Muncie, Indiana, United States, 47304
      • American Health Network, Inc. - Muncie 145
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management, LLC 131
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Frederick OB/GYN 189
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research, Inc. 133
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research Group, LLC 124
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Planned Parenthood of the St. Louis Regions 169
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Office of Edmond Pack, MD 192
    • Las Vegas, Nevada, United States, 89123
      • Clinical Research Center of Nevada 136
    • Las Vegas, Nevada, United States, 89128
      • R. Garn Mabey, Jr., MD, Chartered 116
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Bosque Women's Care 117
  • New York
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates 114
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • PMG Research of Cary 134
    • Morehead City, North Carolina, United States, 28557
      • Unified Women's Clinical Research 125
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center 103
    • Raleigh, North Carolina, United States, 27607
      • Lyndhurst Clinical Research 110
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center 139
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Radient Research, Inc. 152
    • Cleveland, Ohio, United States, 44122
      • Elite Research Network - Rapid Medical Research, Inc. 171
    • Columbus, Ohio, United States, 43213
      • Aventiv 128
    • Columbus, Ohio, United States, 43231
      • Complete Healthcare for Women 151
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia 186
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Medical Research South 126
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • The University of Tennessee Medical Center 188
  • Texas
    • Austin, Texas, United States, 78735
      • Premier Family Physicians 102
    • Beaumont, Texas, United States, 77702
      • Pioneer Research Solutions, Inc. 164
    • Carrollton, Texas, United States, 75010
      • Family Medicine Associates of Texas 106
    • Dallas, Texas, United States, 75230
      • Practice Research Organization 115
    • Fort Worth, Texas, United States, 76104
      • Brownstone Clinical Trials 191
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc. 182
    • Houston, Texas, United States, 77074
      • Southeast Texas Family Planning & Cancer Screening 121
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development. Inc. 150
    • Plano, Texas, United States, 75093
      • North Texas Family Medicine 104
    • San Antonio, Texas, United States, 78212
      • Neera Bhatia, MD OB/GYN 180
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research 187
  • Utah
    • Draper, Utah, United States, 84020
      • Physician's Research Options, LLC 178
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research 183
  • Virginia
    • Centreville, Virginia, United States, 20121
      • PI-Coor Clinical Research, LLC 153
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates of Tidewater 148
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Women's: Health, Research, Gynecology 113

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Inclusion Criteria:

To enroll in the clinical study, potential subjects must:

1. Be healthy women, who are sexually active, at risk of pregnancy, and desiring contraception.
2. Be within the age range of 18 to 35 years old (inclusive) at enrollment.
3. 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.
4. At the time of enrollment, have a single male sex partner for ≥3 months.
5. Have a negative urine pregnancy test at enrollment.

6. 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:

   1. 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.
   2. 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.
   3. If a contraceptive implant was recently removed, the subject must have had at least two consecutive, spontaneous menses prior to the date of consent.
   4. 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.
7. Be willing to engage in at least three acts of heterosexual vaginal intercourse per cycle.
8. 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).
9. 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.
10. 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.
11. Agree not to participate in any other clinical studies during the course of the study.
12. Be capable and willing to give written informed consent to participate in the study.

Exclusion Criteria:

Exclusion Criteria:

To enroll in the clinical study, potential subjects must not:

1. Have had three or more urinary tract infections (UTIs) in the past year from the date of consent.
2. 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.
3. 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.
4. 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).
5. Be pregnant, have a suspected pregnancy, or desire to become pregnant during the course of the study.
6. Have a history of diagnosed infertility or of conditions that may lead to infertility, without subsequent non-assisted reproductive technology intrauterine pregnancy.
7. Have any maternal contraindications to pregnancy (medical condition) or chronic use of medications for which significant evidence of fetal risk exists.
8. Have known or screen test positive for HIV infection.
9. 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.
10. Have visible genital condylomata (warts).
11. Be lactating or breastfeeding.
12. 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.
13. Have clinically significant signs of vaginal or cervical irritation on pelvic examination.
14. Be planning to have any (e.g., diagnostic or therapeutic) vaginal or cervical procedures during the period of the study.

15. Have an abnormal Papanicolaou test (Pap test) based on the following criteria:

    a. 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.

    iv. 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.

    b. 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.

    c. 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.

    d. Pap test in the past 12 months with malignant cells.

16. Consume (on average) more than three drinks of an alcoholic beverage per day.
17. In the opinion of the Investigator, have a history of substance abuse in the last 12 months.
18. Have taken an investigational drug or used an investigational device within the past 30 days from the date of consent.
19. 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.
20. Be an Evofem, PAREXEL, or clinical site employee regardless of direct involvement in research activities, or their close relative.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; This 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.	Drug: AMPHORA; non-hormonal contraceptive vaginal gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy	To evaluate the contraceptive efficacy of Amphora over 7-cycle of use	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Adverse Events (AE)	Incidence of AE to evaluate safety	10 months

Collaborators and Investigators

• Sponsor: Evofem Inc.
• Collaborators: Parexel
• Investigators: Study Director: Kelly Culwell, Evofem Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AMP002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No