AMP002 Phase III Contraceptive Study
Condition: Contraception
Intervention: AMPHORA
Intervention description: non-hormonal contraceptive vaginal gel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Single Arm, unblinded
Masking: None (Open Label)
Enrollment: 1384.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.