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

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.