Clinical trial NCT03243305: AMP002 Phase III Contraceptive 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Evofem Inc.
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2017-08-09
Enrollment: 1384
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Arm, unblinded
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Pregnancy Outcomes to Measure Contraceptive Efficacy
timeFrame: 10 months
Secondary outcomes:
measure: Number of Subjects With Adverse Events (AE)
timeFrame: 10 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Chandler
country: United States
facility: East Valley Family Physicians 137
state: Arizona
city: Mesa
country: United States
facility: Mesa Obstetricians & Gynecologists 184
state: Arizona
city: Phoenix
country: United States
facility: Family Practice Specialists Ltd 170
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials AZ, LLC 176
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research, Inc. 111
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research Tucson 138
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research 185
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic 205
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC 135
state: California
city: Berkeley
country: United States
facility: Essential Access Health 159
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, LLC 163
state: California
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research 119
state: California
city: Sacramento
country: United States
facility: Northern California Research 179
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research 101
state: California
city: San Diego
country: United States
facility: Optimal Research, LLC 149
state: California
city: San Diego
country: United States
facility: Women's Health Care 122
state: California
city: Torrance
country: United States
facility: Harbor - UCLA LABIOMED 143
state: California
city: Upland
country: United States
facility: Empire Clinical Research 175
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies 172
state: Colorado
city: Denver
country: United States
facility: Downtown Women's Healthcare 109
state: Colorado
city: New London
country: United States
facility: Coastal Connecticut Research, LLC 141
state: Connecticut
city: Clearwater
country: United States
facility: Flordia Clinical Research Group, LLC 130
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates 160
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials 108
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab and Research Center 193
state: Florida
city: Hialeah
country: United States
facility: The Community Research of South Florida 167
state: Florida
city: Hialeah
country: United States
facility: Vital Pharma Research, Inc. 123
state: Florida
city: Jacksonville
country: United States
facility: UF Health Woman's Specialist - Emerson 194
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc. 129
state: Florida
city: Lake Worth
country: United States
facility: Altus Research 142
state: Florida
city: Melbourne
country: United States
facility: Optimal Research, LLC 107
state: Florida
city: Miami
country: United States
facility: South Florida Research Center, Inc. 165
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC 156
state: Florida
city: Miami
country: United States
facility: AppleMed Research Group, LLC 154
state: Florida
city: Miami
country: United States
facility: New Horizon Research 155
state: Florida
city: Miami
country: United States
facility: Vista Health Research 166
state: Florida
city: Orlando
country: United States
facility: Heuermd Research, Inc. 140
state: Florida
city: Pembroke Pines
country: United States
facility: Health Care Family Rehab and Research 190
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research 158
state: Florida
city: Wellington
country: United States
facility: Visions Clinical Research 168
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials 161
state: Georgia
city: Roswell
country: United States
facility: Atlanta North Gynecology, PC 120
state: Georgia
city: Blackfoot
country: United States
facility: Elite Clinical Trials 105
state: Idaho
city: Champaign
country: United States
facility: Women's Health Practice 132
state: Illinois
city: Avon
country: United States
facility: American Health Network, Inc. - Avon 144
state: Indiana
city: Fort Wayne
country: United States
facility: Women's Health Advantage 162
state: Indiana
city: Franklin
country: United States
facility: American Health Network, Inc. - Franklin 146
state: Indiana
city: Muncie
country: United States
facility: American Health Network, Inc. - Muncie 145
state: Indiana
city: Covington
country: United States
facility: Clinical Trials Management, LLC 131
state: Louisiana
city: Frederick
country: United States
facility: Frederick OB/GYN 189
state: Maryland
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc. 133
state: Massachusetts
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group, LLC 124
state: Michigan
city: Saint Louis
country: United States
facility: Planned Parenthood of the St. Louis Regions 169
state: Missouri
city: Las Vegas
country: United States
facility: Office of Edmond Pack, MD 192
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada 136
state: Nevada
city: Las Vegas
country: United States
facility: R. Garn Mabey, Jr., MD, Chartered 116
state: Nevada
city: Albuquerque
country: United States
facility: Bosque Women's Care 117
state: New Mexico
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates 114
state: New York
city: Cary
country: United States
facility: PMG Research of Cary 134
state: North Carolina
city: Morehead City
country: United States
facility: Unified Women's Clinical Research 125
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center 103
state: North Carolina
city: Raleigh
country: United States
facility: Lyndhurst Clinical Research 110
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center 139
state: North Carolina
city: Cincinnati
country: United States
facility: Radient Research, Inc. 152
state: Ohio
city: Cleveland
country: United States
facility: Elite Research Network - Rapid Medical Research, Inc. 171
state: Ohio
city: Columbus
country: United States
facility: Aventiv 128
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women 151
state: Ohio
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia 186
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Research South 126
state: South Carolina
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center 188
state: Tennessee
city: Austin
country: United States
facility: Premier Family Physicians 102
state: Texas
city: Beaumont
country: United States
facility: Pioneer Research Solutions, Inc. 164
state: Texas
city: Carrollton
country: United States
facility: Family Medicine Associates of Texas 106
state: Texas
city: Dallas
country: United States
facility: Practice Research Organization 115
state: Texas
city: Fort Worth
country: United States
facility: Brownstone Clinical Trials 191
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc. 182
state: Texas
city: Houston
country: United States
facility: Southeast Texas Family Planning & Cancer Screening 121
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development. Inc. 150
state: Texas
city: Plano
country: United States
facility: North Texas Family Medicine 104
state: Texas
city: San Antonio
country: United States
facility: Neera Bhatia, MD OB/GYN 180
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research 187
state: Texas
city: Draper
country: United States
facility: Physician's Research Options, LLC 178
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research 183
state: Utah
city: Centreville
country: United States
facility: PI-Coor Clinical Research, LLC 153
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater 148
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology 113
state: Washington
Study officials:
affiliation: Evofem Inc.
name: Kelly Culwell
role: STUDY_DIRECTOR
References: