AMP002 Phase III Contraceptive Study

NCT03243305 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AMP002
• Study Type: interventional
• Target: 1,384
• Locations: 1 country
• Sites: 87

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Subjects With Adverse Events (AE)

  10 months

Study Arms (1)

Interventional

EXPERIMENTAL

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

Interventions

AMPHORA DRUG

non-hormonal contraceptive vaginal gel

Interventional

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Evofem Inc.: lead
• Parexel: collaborator

Study Sites (87)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

East Valley Family Physicians 137

Chandler, Arizona, 85224, United States

Location

Mesa Obstetricians & Gynecologists 184

Mesa, Arizona, 85209, United States

Location

Family Practice Specialists Ltd 170

Phoenix, Arizona, 85018, United States

Location

Precision Trials AZ, LLC 176

Phoenix, Arizona, 85032, United States

Location

Radiant Research, Inc. 111

Scottsdale, Arizona, 85251, United States

Location

Visions Clinical Research Tucson 138

Tucson, Arizona, 85712, United States

Location

Eclipse Clinical Research 185

Tucson, Arizona, 85745, United States

Location

Arkansas Primary Care Clinic 205

Little Rock, Arkansas, 72204, United States

Location

Anaheim Clinical Trials, LLC 135

Anaheim, California, 92801, United States

Location

Essential Access Health 159

Berkeley, California, 94710, United States

Location

Hope Clinical Research, LLC 163

Canoga Park, California, 91303, United States

Location

Grossmont Center for Clinical Research 119

La Mesa, California, 91942, United States

Location

Northern California Research 179

Sacramento, California, 95821, United States

Location

Medical Center for Clinical Research 101

San Diego, California, 92108, United States

Location

Optimal Research, LLC 149

San Diego, California, 92108, United States

Location

Women's Health Care 122

San Diego, California, 92123, United States

Location

Harbor - UCLA LABIOMED 143

Torrance, California, 90502, United States

Location

Empire Clinical Research 175

Upland, California, 91786, United States

Location

Lynn Institute of the Rockies 172

Colorado Springs, Colorado, 80920, United States

Location

Downtown Women's Healthcare 109

Denver, Colorado, 80209, United States

Location

Coastal Connecticut Research, LLC 141

New London, Connecticut, 06320, United States

Location

Flordia Clinical Research Group, LLC 130

Clearwater, Florida, 33759, United States

Location

Clinical Physiology Associates 160

Fort Myers, Florida, 33912, United States

Location

AGA Clinical Trials 108

Hialeah, Florida, 33012, United States

Location

Health Care Family Rehab and Research Center 193

Hialeah, Florida, 33012, United States

Location

The Community Research of South Florida 167

Hialeah, Florida, 33016, United States

Location

Vital Pharma Research, Inc. 123

Hialeah, Florida, 33016, United States

Location

UF Health Woman's Specialist - Emerson 194

Jacksonville, Florida, 32207, United States

Location

Health Awareness, Inc. 129

Jupiter, Florida, 33458, United States

Location

Altus Research 142

Lake Worth, Florida, 33461, United States

Location

Optimal Research, LLC 107

Melbourne, Florida, 32934, United States

Location

South Florida Research Center, Inc. 165

Miami, Florida, 33135, United States

Location

Advanced Pharma CR, LLC 156

Miami, Florida, 33147, United States

Location

AppleMed Research Group, LLC 154

Miami, Florida, 33155, United States

Location

New Horizon Research 155

Miami, Florida, 33155, United States

Location

Vista Health Research 166

Miami, Florida, 33176, United States

Location

Heuermd Research, Inc. 140

Orlando, Florida, 32819, United States

Location

Health Care Family Rehab and Research 190

Pembroke Pines, Florida, 33024, United States

Location

Physician Care Clinical Research 158

Sarasota, Florida, 34239, United States

Location

Visions Clinical Research 168

Wellington, Florida, 33414, United States

Location

Agile Clinical Research Trials 161

Atlanta, Georgia, 30328, United States

Location

Atlanta North Gynecology, PC 120

Roswell, Georgia, 30075, United States

Location

Elite Clinical Trials 105

Blackfoot, Idaho, 83221, United States

Location

Women's Health Practice 132

Champaign, Illinois, 61820, United States

Location

American Health Network, Inc. - Avon 144

Avon, Indiana, 46123, United States

Location

Women's Health Advantage 162

Fort Wayne, Indiana, 46825, United States

Location

American Health Network, Inc. - Franklin 146

Franklin, Indiana, 46131, United States

Location

American Health Network, Inc. - Muncie 145

Muncie, Indiana, 47304, United States

Location

Clinical Trials Management, LLC 131

Covington, Louisiana, 70433, United States

Location

Frederick OB/GYN 189

Frederick, Maryland, 21702, United States

Location

ActivMed Practices & Research, Inc. 133

Methuen, Massachusetts, 01844, United States

Location

Saginaw Valley Medical Research Group, LLC 124

Saginaw, Michigan, 48604, United States

Location

Planned Parenthood of the St. Louis Regions 169

St Louis, Missouri, 63108, United States

Location

Office of Edmond Pack, MD 192

Las Vegas, Nevada, 89106, United States

Location

Clinical Research Center of Nevada 136

Las Vegas, Nevada, 89123, United States

Location

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

Las Vegas, Nevada, 89128, United States

Location

Bosque Women's Care 117

Albuquerque, New Mexico, 87109, United States

Location

Upstate Clinical Research Associates 114

Williamsville, New York, 14221, United States

Location

PMG Research of Cary 134

Cary, North Carolina, 27518, United States

Location

Unified Women's Clinical Research 125

Morehead City, North Carolina, 28557, United States

Location

Eastern Carolina Women's Center 103

New Bern, North Carolina, 28562, United States

Location

Lyndhurst Clinical Research 110

Raleigh, North Carolina, 27607, United States

Location

Southeastern Research Center 139

Winston-Salem, North Carolina, 27103, United States

Location

Radient Research, Inc. 152

Cincinnati, Ohio, 45236, United States

Location

Elite Research Network - Rapid Medical Research, Inc. 171

Cleveland, Ohio, 44122, United States

Location

Aventiv 128

Columbus, Ohio, 43213, United States

Location

Complete Healthcare for Women 151

Columbus, Ohio, 43231, United States

Location

Clinical Research of Philadelphia 186

Philadelphia, Pennsylvania, 19114, United States

Location

Medical Research South 126

Charleston, South Carolina, 29407, United States

Location

The University of Tennessee Medical Center 188

Knoxville, Tennessee, 37920, United States

Location

Premier Family Physicians 102

Austin, Texas, 78735, United States

Location

Pioneer Research Solutions, Inc. 164

Beaumont, Texas, 77702, United States

Location

Family Medicine Associates of Texas 106

Carrollton, Texas, 75010, United States

Location

Practice Research Organization 115

Dallas, Texas, 75230, United States

Location

Brownstone Clinical Trials 191

Fort Worth, Texas, 76104, United States

Location

Centex Studies, Inc. 182

Houston, Texas, 77058, United States

Location

Southeast Texas Family Planning & Cancer Screening 121

Houston, Texas, 77074, United States

Location

Texas Center for Drug Development. Inc. 150

Houston, Texas, 77081, United States

Location

North Texas Family Medicine 104

Plano, Texas, 75093, United States

Location

Neera Bhatia, MD OB/GYN 180

San Antonio, Texas, 78212, United States

Location

Progressive Clinical Research 187

San Antonio, Texas, 78213, United States

Location

Physician's Research Options, LLC 178

Draper, Utah, 84020, United States

Location

Wasatch Clinical Research 183

Salt Lake City, Utah, 84107, United States

Location

PI-Coor Clinical Research, LLC 153

Centreville, Virginia, 20121, United States

Location

Clinical Research Associates of Tidewater 148

Norfolk, Virginia, 23507, United States

Location

Seattle Women's: Health, Research, Gynecology 113

Seattle, Washington, 98105, United States

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Evofem, Inc.

kculwell@evofem.com

858 550 1900

Study Officials

• Kelly Culwell

  Evofem Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm, unblinded

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: August 9, 2017
• Study Start: July 24, 2017
• Primary Completion: November 29, 2018
• Study Completion: November 29, 2018
• Last Updated: September 17, 2020
• Results First Posted: July 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (87)