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

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).

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