AMP002 Phase III Contraceptive Study

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243305
• Other study ID #: AMP002
• Status: Completed
• Phase: Phase 3
• Start date: July 24, 2017
• Est. completion date: November 29, 2018

Study information

• Verified date: September 2020
• Source: Evofem Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1384
• Est. completion date: November 29, 2018
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• AMPHORA
non-hormonal contraceptive vaginal gel

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Evofem Inc.	Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Subjects With Adverse Events (AE)	Incidence of AE to evaluate safety	10 months