AMP002 Phase III Contraceptive Study

NCT ID: NCT03243305

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2018-11-29

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.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AMPHORA

Intervention Type: DRUG

non-hormonal contraceptive vaginal gel

Interventions

AMPHORA

non-hormonal contraceptive vaginal gel

Intervention Type: DRUG

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

Evofem Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Culwell

Role: STUDY_DIRECTOR

Evofem Inc.

Locations

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

East Valley Family Physicians 137

Chandler, Arizona, United States

Mesa Obstetricians & Gynecologists 184

Mesa, Arizona, United States

Family Practice Specialists Ltd 170

Phoenix, Arizona, United States

Precision Trials AZ, LLC 176

Phoenix, Arizona, United States

Radiant Research, Inc. 111

Scottsdale, Arizona, United States

Visions Clinical Research Tucson 138

Tucson, Arizona, United States

Eclipse Clinical Research 185

Tucson, Arizona, United States

Arkansas Primary Care Clinic 205

Little Rock, Arkansas, United States

Anaheim Clinical Trials, LLC 135

Anaheim, California, United States

Essential Access Health 159

Berkeley, California, United States

Hope Clinical Research, LLC 163

Canoga Park, California, United States

Grossmont Center for Clinical Research 119

La Mesa, California, United States

Northern California Research 179

Sacramento, California, United States

Medical Center for Clinical Research 101

San Diego, California, United States

Optimal Research, LLC 149

San Diego, California, United States

Women's Health Care 122

San Diego, California, United States

Harbor - UCLA LABIOMED 143

Torrance, California, United States

Empire Clinical Research 175

Upland, California, United States

Lynn Institute of the Rockies 172

Colorado Springs, Colorado, United States

Downtown Women's Healthcare 109

Denver, Colorado, United States

Coastal Connecticut Research, LLC 141

New London, Connecticut, United States

Flordia Clinical Research Group, LLC 130

Clearwater, Florida, United States

Clinical Physiology Associates 160

Fort Myers, Florida, United States

AGA Clinical Trials 108

Hialeah, Florida, United States

Health Care Family Rehab and Research Center 193

Hialeah, Florida, United States

The Community Research of South Florida 167

Hialeah, Florida, United States

Vital Pharma Research, Inc. 123

Hialeah, Florida, United States

UF Health Woman's Specialist - Emerson 194

Jacksonville, Florida, United States

Health Awareness, Inc. 129

Jupiter, Florida, United States

Altus Research 142

Lake Worth, Florida, United States

Optimal Research, LLC 107

Melbourne, Florida, United States

South Florida Research Center, Inc. 165

Miami, Florida, United States

Advanced Pharma CR, LLC 156

Miami, Florida, United States

AppleMed Research Group, LLC 154

Miami, Florida, United States

New Horizon Research 155

Miami, Florida, United States

Vista Health Research 166

Miami, Florida, United States

Heuermd Research, Inc. 140

Orlando, Florida, United States

Health Care Family Rehab and Research 190

Pembroke Pines, Florida, United States

Physician Care Clinical Research 158

Sarasota, Florida, United States

Visions Clinical Research 168

Wellington, Florida, United States

Agile Clinical Research Trials 161

Atlanta, Georgia, United States

Atlanta North Gynecology, PC 120

Roswell, Georgia, United States

Elite Clinical Trials 105

Blackfoot, Idaho, United States

Women's Health Practice 132

Champaign, Illinois, United States

American Health Network, Inc. - Avon 144

Avon, Indiana, United States

Women's Health Advantage 162

Fort Wayne, Indiana, United States

American Health Network, Inc. - Franklin 146

Franklin, Indiana, United States

American Health Network, Inc. - Muncie 145

Muncie, Indiana, United States

Clinical Trials Management, LLC 131

Covington, Louisiana, United States

Frederick OB/GYN 189

Frederick, Maryland, United States

ActivMed Practices & Research, Inc. 133

Methuen, Massachusetts, United States

Saginaw Valley Medical Research Group, LLC 124

Saginaw, Michigan, United States

Planned Parenthood of the St. Louis Regions 169

St Louis, Missouri, United States

Office of Edmond Pack, MD 192

Las Vegas, Nevada, United States

Clinical Research Center of Nevada 136

Las Vegas, Nevada, United States

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

Las Vegas, Nevada, United States

Bosque Women's Care 117

Albuquerque, New Mexico, United States

Upstate Clinical Research Associates 114

Williamsville, New York, United States

PMG Research of Cary 134

Cary, North Carolina, United States

Unified Women's Clinical Research 125

Morehead City, North Carolina, United States

Eastern Carolina Women's Center 103

New Bern, North Carolina, United States

Lyndhurst Clinical Research 110

Raleigh, North Carolina, United States

Southeastern Research Center 139

Winston-Salem, North Carolina, United States

Radient Research, Inc. 152

Cincinnati, Ohio, United States

Elite Research Network - Rapid Medical Research, Inc. 171

Cleveland, Ohio, United States

Aventiv 128

Columbus, Ohio, United States

Complete Healthcare for Women 151

Columbus, Ohio, United States

Clinical Research of Philadelphia 186

Philadelphia, Pennsylvania, United States

Medical Research South 126

Charleston, South Carolina, United States

The University of Tennessee Medical Center 188

Knoxville, Tennessee, United States

Premier Family Physicians 102

Austin, Texas, United States

Pioneer Research Solutions, Inc. 164

Beaumont, Texas, United States

Family Medicine Associates of Texas 106

Carrollton, Texas, United States

Practice Research Organization 115

Dallas, Texas, United States

Brownstone Clinical Trials 191

Fort Worth, Texas, United States

Centex Studies, Inc. 182

Houston, Texas, United States

Southeast Texas Family Planning & Cancer Screening 121

Houston, Texas, United States

Texas Center for Drug Development. Inc. 150

Houston, Texas, United States

North Texas Family Medicine 104

Plano, Texas, United States

Neera Bhatia, MD OB/GYN 180

San Antonio, Texas, United States

Progressive Clinical Research 187

San Antonio, Texas, United States

Physician's Research Options, LLC 178

Draper, Utah, United States

Wasatch Clinical Research 183

Salt Lake City, Utah, United States

PI-Coor Clinical Research, LLC 153

Centreville, Virginia, United States

Clinical Research Associates of Tidewater 148

Norfolk, Virginia, United States

Seattle Women's: Health, Research, Gynecology 113

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AMP002

Identifier Type: -

Identifier Source: org_study_id