• Renew Health CR

Now Enrolling Patients For Chlamydia/Gonnorhea Clinical Trial: Last Subject enrolled Feb 2019

Title: Phase 2B/3 double-blinded placebo-controlled efficacy trial of AMPHORA® gel for the prevention of acquisition of urogenital Chlamydia trachomatis infection

All patients must me the following inclusion and exclusion criteria to qualify:

Inclusion Criteria:

1. Healthy female subjects between 18 and 35 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 that is not directly delivered to the vaginal mucosa throughout the duration of the study, such as oral contraceptives, birth control implants, IUDs, or tubal ligation. 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. Consume (on average) more than three drinks of an alcoholic beverage per day.

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

4. 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

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

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

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

8. Inability to provide informed consent.

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

10. 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).

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

12. 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:

a. Azithromycin

b. Erythromycin

c. Tetracycline

d. Minocycline

e. Doxycycline

f. Levofloxacin

g. Ofloxacin

h. Ceftriaxone

i. Cefixime

13. 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.

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

15. 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.

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

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