Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel

Contraception Clinical Trial

Official title:

A Multicenter, Open-Label, Randomized Study of the Contraceptive Efficacy and Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306331
• Other study ID #: AMP001
• Status: Completed
• Phase: Phase 3
• Start date: April 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2022
• Source: Evofem Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a research study of a new experimental vaginal gel that helps in vaginal pH regulation and results in immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen. This vaginal gel is called Phexxi™ (previously known as Amphora) and was compared to a commercially available spermicide called Conceptrol®, which contains nonoxynol 9; commonly abbreviated as N-9. Conceptrol® can help prevent pregnancy. This study objective was to determine if this product prevents pregnancy when inserted into the vagina before intercourse.

Description:

Clinical Trial Design

This is a multicenter, open-label, randomized, controlled, Phase III study of repeated use of Amphora™ gel compared to Conceptrol® Vaginal Gel as the method of contraception over seven cycles of use. In addition, there is an opportunity for Amphora™ gel subjects to continue with study treatment for up to 13 cycles of treatment upon completion of the first seven cycles of treatment.

A subset of subjects (Amphora™ gel and Conceptrol® Vaginal Gel) will undergo colposcopy at the Admission Visit and at the visits after Cycles 1, 3, and 7 (Treatment Exit). Subjects participating for 13 cycles will also undergo colposcopy after Cycles 10 and 13. Colposcopic photographs will be taken at all visits independent of presence of any suspicious areas. Any suspicious areas and clinical findings will be recorded on the colposcopy case report form. The colposcopy evaluator for the subset will be blinded regarding the treatment group of the subject. If at any time during the study the investigator deems colposcopy necessary, colposcopy will be performed on any subject and will not be limited to subjects in the colposcopy subset.

A subset of subjects (Amphora™ gel and Conceptrol® Vaginal Gel) will also have semi-quantitative cultures for E. coli and clinical yeast performed at the Admission Visit and after Cycles 1, 3, and 7 (Treatment Exit) Visits. Subjects participating for 13 cycles will also undergo the assessments after Cycles 10 and 13. Another subgroup will have quantitative vaginal cultures performed after Cycles 1 and 7 (Treatment Exit) Visits, and also after Cycle 13 for subjects participating in the extension.

Selected research centers will also recruit subjects into the subset of women 36-45 years of age at enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3389
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Be healthy women, who are sexually active, at risk for pregnancy, and desiring contraception.

• Be within the age range of 18 through 35 (inclusive) at enrollment if not in the subset of women with an age of 36-45 at enrollment (age subset at select sites).

• Be at low-risk for both human immunodeficiency virus (HIV) and sexually transmitted disease (STD) infection and currently have a single sex partner (= 4 months) who is also at low-risk for both HIV and STD infection.

• Have a negative urine pregnancy test prior to enrollment.

• Have normal cyclic menses with a usual length of 21 to 40 days over the last two cycles or at least one spontaneous, normal menstrual cycle (two menses) since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy.

• Be willing to accept a risk of pregnancy.

• Be willing to engage in at least two acts of heterosexual vaginal intercourse per cycle.

• Be willing to be randomized to either study treatment.

• Be willing to use the study product as the only method of contraception over the course of the study (with the exception of emergency contraception (EC)), when indicated).

• Be capable of using the study product properly and agree to observe all study directions and requirements.

• Be willing to keep a daily diary to record coital information, product use information, information about the use of other vaginal products, and sign and symptom data for both the subject and her partner.

• Agree not to participate in any other clinical trials during the course of the study with the exception of enrolling in the Amphora™ gel extension study.

• Be willing to give written informed consent to participate in the trial.

Exclusion Criteria:

• Have a history of allergy or sensitivity to spermicides or products containing N-9 (nonoxynol-9).

• Have had three or more urinary tract infections (UTIs) in the past year.

• Have a UTI by urine culture, symptomatic yeast vaginitis, or symptomatic bacterial vaginosis diagnosed by wet mount unless treated and proof of cure is documented.

• Have a history of any recurrent vaginal infections/disorders (either less than or equal to four times in the past year or less than or equal to three times in the previous six months).

• Be pregnant, have a suspected pregnancy, or desire to become pregnant during the course of the study.

• Have a history of infertility or of conditions that may lead to infertility, without subsequent intrauterine pregnancy.

• Have any contraindications to pregnancy (medical condition) or chronic use of medications for which significant evidence of fetal risk exists.

• Have had more than one sexual partner in the last four months.

• Have shared injection drug needles in the past unless has a negative HIV test at least six weeks since last use.

• Have or have been suspected to have HIV infection.

• Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within three months prior to screening.

• Have three or more outbreaks of HSV within the last year.

• Have evidence of Chlamydia trachomatis or Neisseria gonorrhoeae unless she and her partner complete treatment and proof of cure is documented.

• Have been diagnosed with any other STDs in the six months prior to the Randomization Visit (with the exception of human papillomavirus (HPV), trichomonas, gonorrhea, adn Chlamydia).

• Be lactating or breastfeeding.

• Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening.

• Have any clinically significant abnormal finding on pelvic examination or baseline labs, which in the view of the investigator, precludes her from participating in the trial.

• Have clinically significant signs of vaginal or cervical irritation on pelvic examination.

• Have had vaginal or cervical biopsy or vaginal surgery within three months prior to screening (with the exception of cervical biopsies performed for eligibility determination).

• Have used vaginal or systemic antibiotics or antifungals within 14 days prior to screening or enrollment/randomization, with the exception of systemic antibiotics taken for a UTI and trichomonas diagnosed at screening. Subjects should not have used systemic antibiotics prescribed at the Screening Visit for a UTI within seven days of the enrollment/randomization visit.

• Have had a Depo-Provera® injection in the ten months prior to enrollment.

• Have an abnormal Pap test based on the following criteria:

• Pap test in the past 15 months with ASC-US unless:

• less than 21 years of age;

• a repeat Pap test at least six months later was normal;

• reflex HPV testing was performed and was negative for high-risk HPV; or

• 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;

• Pap test in the past 15 months with LSIL unless:

• less than 21 years of age;

• 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;

• Pap test in the past 15 months with ASC-H, atypical glandular cells, or HSIL 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;

• Pap test in the past 15 months with malignant cells.

• Consume (on average) greater than three drinks of an alcoholic beverage per day.

• Have a past history (within 12 months) or current history which, in the PI's judgment, constitutes of drug abuse (recreational, prescription, or over-the-counter (OTC)).

• Have taken an investigational drug or used an investigational device within the past 30 days.

• Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.

In addition, in order to be eligible to participate in the trial, potential subjects must state that, to her best knowledge, her sexual partner meets the following criteria:

• Is not infertile.

• Has had untreated chlamydia or gonorrhea in the past six months.

• Has not had more than one sexual partner in the past four months.

• Has no history of allergy or sensitivity to spermicides or products containing N-9.

• Has not been previously diagnosed with or suspected of HIV infection unless he has subsequently had a negative HIV test.

• Has not been known to have engaged in homosexual intercourse in the past five years unless he has had negative HIV test results since then.

• Has not shared injection drug needles in the past unless he has had a negative HIV test at least six weeks since last use.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Conceptrol
• Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.
• Amphora
• Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.

Locations

Country	Name	City	State
Russian Federation	Ural Scientific Research Institution of Maternity and Child Protection	Ekaterinburg
Russian Federation	Kazan State Medical University	Kazan	Republic Tatarstan
Russian Federation	City Clinical Hospital #13	Moscow
Russian Federation	City Clinical Hospital #31	Moscow
Russian Federation	First Moscow State Medical University named after IM Sechenov	Moscow
Russian Federation	Moscow Regional Research Institute of Obstetrics and Gynecology	Moscow
Russian Federation	State Budgetary Institution fo Rostov region "Parinatal Center"	Rostov-na-Donu	Rostov Region
Russian Federation	Maternity Hospital #17	Saint Petersburg
Russian Federation	Medical Center "Prime-Rose"LLC	Saint Petersburg
Russian Federation	The DO Ott Research Institute of Obstetrics and Gynecology	Saint Petersburg
Russian Federation	Hospital OrCli	Saint-Petersburg
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Johns Hopkins Community Physicians	Baltimore	Maryland
United States	California Family Health Council, Inc.	Berkeley	California
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Meridien Research	Bradenton	Florida
United States	University of Cincinnati	Cincinnati	Ohio
United States	Planned Parenthood of Northeast Ohio	Cleveland	Ohio
United States	Advanced Research Associates	Corpus Christi	Texas
United States	Practice Research Organization	Dallas	Texas
United States	UT Southwestern Medical Center - Dept. of OB/GYN	Dallas	Texas
United States	Soapstone Center for Clinical Research	Decatur	Georgia
United States	Avail Clinical Reseach	DeLand	Florida
United States	Downtown Women's Healthcare	Denver	Colorado
United States	Planned Parenthood of the Rocky Mountains	Denver	Colorado
United States	TMC Life Research, Inc	Houston	Texas
United States	Rosemark WomenCare Specialist	Idaho Falls	Idaho
United States	MacArthur OB/GYN	Irving	Texas
United States	Altus Research	Lake Worth	Florida
United States	Impact Clinical Trials	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	California Family and Health Council, Inc., LA	Los Angeles	California
United States	California Family Health Council	Los Angeles	California
United States	Miami Research Associates	Miami	Florida
United States	Eastern Carolina Women's Center	New Bern	North Carolina
United States	Columbia University Medical Center, Division of Family Planning	New York	New York
United States	NYU Medical Center Family Planning	New York	New York
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Philadelphia Clinical Research	Philadelphia	Pennsylvania
United States	University of Pennsylvania Medical Center, Reproductive Research Unit	Philadelphia	Pennsylvania
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	Meridien Research	Saint Petersburg	Florida
United States	Jean Brown Research	Salt Lake City	Utah
United States	Women's Health Care	San Diego	California
United States	Women's Clinical Research Center	Seattle	Washington
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Comprehensive Clinical Trials	West Palm Beach	Florida
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Evofem Inc.	Health Decisions

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-Month (183 Days) Cumulative Pregnancy Percentage	The primary endpoint was the evaluation of contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the MITT population by treatment group	183 days
Secondary	6-Month (183 Days) Cumulative Pregnancy Percentage for Subjects With Perfect Use	Perfect use contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the efficacy evaluable (EE) population by treatment group	183 days