Phase 2B/3 Double-blinded Placebo-controlled

Primary: To determine if intravaginal Amphora gel reduces the risk of urogenital Chlamydia
trachomatis (CT) infection.

Secondary: To determine if intravaginal Amphora gel reduces the risk of urogenital Neisseria
gonorrhoeae (GC) infection.

Exploratory:To determine if Amphora gel use rate (subject adherence to instructed use) has an
effect on proportion of subjects who experience at least one CT or GC infection during the
study intervention period.

Primary Outcome Measures: Proportion of subjects who experience at least one urogenital CT
infection during the study intervention period (incident infection of CT).

Secondary Outcome Measures: Proportion of subjects who experience at least one urogenital GC
infection during the study intervention period (incident infection of GC).

Exploratory Outcome Measures:

- Compliance with Amphora gel usage during study (rate of product use adherence).

- Sensitivity analyses of the primary parameter (proportion of subjects who experience at
least one CT or GC infection during the study intervention period) will be performed for
the following:

- Subjects with ≥20%, ≥40%, ≥60% and ≥80% product use adherence

- Subject Satisfaction

- Sexual satisfaction

Inclusion Criteria:

1. Healthy female subjects between 18 and 45 years, inclusive

2. Ability to understand the consent process and procedures

3. Subjects agree to be available for all study visits

4. Written informed consent in accordance with institutional guidelines

5. Negative pregnancy test

6. Negative CT and GC NAAT tests OR positive CT or GC NAAT and receives standard of care
(SOC) treatment

7. Agree to use a woman-controlled method of contraception, such as oral contraceptives,
vaginal ring, birth control implants, IUDs, or tubal ligation (with the exception of
spermicides, diaphragms, or any vaginally applied or inserted products containing
nonoxynol-9). Condom use only is not an acceptable form of contraception for this
study.

8. Able and willing to comply with all study procedures

9. Documented (as part of a retrievable medical record) CT or GC infection within 16
weeks prior to enrollment

10. Reports vaginal sexual intercourse with a male partner at least 3 times per month in
the previous month and anticipates vaginal sexual intercourse regularly for the
duration of the study

11. Agree to abstain from douching or any form of vaginal suppository use (other than
study product) during course of study

Exclusion Criteria:

1. Participation in any study with an investigational compound or device within 30 days
prior to signing informed consent

2. In the opinion of the Investigator, have a history of substance abuse in the last 12
months

3. In the opinion of the Investigator, have issues, conditions, 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

4. Be an Evofem, ClinicalRM, or clinical site employee regardless of direct involvement
in research activities, or their close relative

5. Pregnant (or actively trying to become pregnant), or breast-feeding

6. Women who have undergone a total hysterectomy (had uterus and cervix removed)

7. Inability to provide informed consent

8. A subject with a history or expectation of noncompliance with medications or
intervention protocol

9. Have engaged in sexual intercourse, douching or used of any form of vaginal
suppository or intravaginal device for 24 hours prior to enrollment (may be enrolled
at a later date if all other criteria are met)

10. Menstruating at enrollment (may be enrolled at a later date if all other criteria are
met)

11. Women who are currently being treated, or have been treated, for a period of 14 days
prior to enrollment, with specific antibiotics known to be used for the treatment of
CT or GC:

1. Azithromycin

2. Erythromycin

3. Tetracycline

4. Minocycline

5. Doxycycline

6. Levofloxacin

7. Ofloxacin

8. Ceftriaxone

9. Cefixime

12. In the opinion of the Investigator, has signs/symptoms that indicate persistence of
chlamydia or gonorrhea infection diagnosed at screening, new interval infection and/or
a failure to comply with or complete the prescribed treatment regimen following a
positive screening NAAT.

13. Women who regularly use douches, vaginal medications, products, or suppositories

14. Women who are currently using contraceptive products that are directly delivered to
the vaginal mucosa, such as diaphragms, vaginal rings (e.g. NuvaRing®), spermicides,
or any vaginally applied or inserted products containing nonoxynol-9.

15. Children, pregnant women, prisoners, and other vulnerable populations