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ContraceptionPhase 3NCT01306331

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

A Phase 3 study testing Conceptrol and Amphora in people with Contraception, run by Evofem Inc. at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Conceptrol and Amphora
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,389 participants
Where
52 sitesin 2 countries
Study dates
Apr 2011to Jun 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 44Show fewer
  • 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.

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States41 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Johns Hopkins Community Physicians

    Baltimore, Maryland, 21211

  • California Family Health Council, Inc.

    Berkeley, California, 94710

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Meridien Research

    Bradenton, Florida, 34208

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Planned Parenthood of Northeast Ohio

    Cleveland, Ohio, 44302

  • Advanced Research Associates

    Corpus Christi, Texas, 78414

  • Practice Research Organization

    Dallas, Texas, 75230

  • UT Southwestern Medical Center - Dept. of OB/GYN

    Dallas, Texas, 75390

  • Soapstone Center for Clinical Research

    Decatur, Georgia, 30034

  • Avail Clinical Reseach

    DeLand, Florida, 32720

  • Downtown Women's Healthcare

    Denver, Colorado, 61820

  • Planned Parenthood of the Rocky Mountains

    Denver, Colorado, 80302

  • TMC Life Research, Inc

    Houston, Texas, 77054

  • Rosemark WomenCare Specialist

    Idaho Falls, Idaho, 83404

  • MacArthur OB/GYN

    Irving, Texas, 75062

  • Altus Research

    Lake Worth, Florida, 33461

  • Impact Clinical Trials

    Las Vegas, Nevada, 89106

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • California Family and Health Council, Inc., LA

    Los Angeles, California, 90010

  • California Family Health Council

    Los Angeles, California, 90010

  • Miami Research Associates

    Miami, Florida, 33143

  • Eastern Carolina Women's Center

    New Bern, North Carolina, 28562

  • NYU Medical Center Family Planning

    New York, New York, 10016

  • Columbia University Medical Center, Division of Family Planning

    New York, New York, 10032

  • Segal Institute for Clinical Research

    North Miami, Florida, 33161

  • University of Pennsylvania Medical Center, Reproductive Research Unit

    Philadelphia, Pennsylvania, 19104

  • Philadelphia Clinical Research

    Philadelphia, Pennsylvania, 19114

  • Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Women's Health Care

    San Diego, California, 92123

  • Women's Clinical Research Center

    Seattle, Washington, 98105

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06095

  • Comprehensive Clinical Trials

    West Palm Beach, Florida, 33409

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

Other trials in United States

Russia11 sites

  • Kazan State Medical University

    Kazan', Republic Tatarstan, 420012

  • Moscow Regional Research Institute of Obstetrics and Gynecology

    Moscow, 101000

  • City Clinical Hospital #13

    Moscow, 115280

  • City Clinical Hospital #31

    Moscow, 119415

  • First Moscow State Medical University named after IM Sechenov

    Moscow, 119991

  • State Budgetary Institution fo Rostov region "Parinatal Center"

    Rostov-on-Don, Rostov Oblast, 344068

  • Maternity Hospital #17

    Saint Petersburg, 195257

  • Medical Center "Prime-Rose"LLC

    Saint Petersburg, 197374

  • The DO Ott Research Institute of Obstetrics and Gynecology

    Saint Petersburg, 199034

  • Hospital OrCli

    Saint Petersburg, 199178

  • Ural Scientific Research Institution of Maternity and Child Protection

    Yekaterinburg, 620028

Other trials in Russia

About this study

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

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.

Read the detailed 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.

Conditions
Contraception
Being tested
Conceptrol, Amphora

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ConceptrolDrug

    • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

  • AmphoraDrug

    • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
Study groups in NCT01306331
Study groupRoleWhat they receive
ConceptrolActive comparator100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel
Receives: Drug: Conceptrol
AmphoraExperimentalCitric acid USP, potassium bitartrate USP, and L-lactic acid USP
Receives: Drug: Amphora

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 183 days

Secondary outcomes (1)

  1. 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

    Measured: 183 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,389 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01306331
Sponsor's protocol ID
AMP001
Status last verified
Jun 2022
First submitted
28 Feb 2011
Last updated
12 Jul 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Conceptrol and Amphora in people with Contraception, run by Evofem Inc. at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-Month (183 Days) Cumulative Pregnancy Percentage (time frame: 183 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01306331.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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