Clinical trial: A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101 (NCT03537092)

Eligibility criteria:
Inclusion Criteria:

        Women must meet all the following criteria to be eligible for inclusion in the study:

          1. Age 18 through 45 years (inclusive) at screening

          2. Able and willing to provide written informed consent to be screened for and to take
             part in the study.

          3. Able and willing to provide adequate locator information

          4. HIV-uninfected based on testing performed by study staff at screening (per algorithm
             in Appendix II)

          5. In general good health as determined by the site clinician

          6. Agree to be sexually abstinent for 48 hours prior to each visit and from Visit 2 to
             Visit 3

          7. At screening, agrees to abstain from any other intravaginal product or penetration
             (including sex toys, excluding tampons) for 48 hours prior to each visit and between
             Visit 2 and 3.

          8. Willingness to undergo all study-related assessments and follow all study-related
             procedures

          9. At screening and enrollment, agrees not to participate in other research studies
             involving drugs, medical devices, or vaginal products while enrolled in this trial

        Exclusion Criteria:

        Women who meet any of the following criteria by participant report will be excluded from
        the study. Of note, the study is limited to premenopausal women with an intact uterus
        because the mucosal immune environment differs substantially between pre- and post-
        menopausal women. Therefore, inclusion of post-menopausal women would introduce
        heterogeneity into the population.

          1. Menopause (as defined as amenorrhea for one year or more without an alternative
             etiology)

          2. Hysterectomy

          3. Participant report of any of the following:

               1. Known adverse reaction to any of the study products (ever)

               2. Known adverse reaction to latex (ever)

               3. Non- therapeutic injection drug use in the 12 months prior to Screening

               4. Surgical procedure involving the pelvis in the 90 days prior to enrollment
                  (includes dilation and curettage or evacuation, and cryosurgery; does not include
                  cervical biopsy for evaluation of an abnormal pap smear)

               5. Participation in a drug, spermicide and/or microbicide study in the 30 days prior
                  to enrollment or anticipated participation in an investigational drug study until
                  completion of the study

               6. Currently pregnant or pregnancy within 42 days prior to enrollment

               7. Currently lactating

               8. Use of a diaphragm, NuvaRing®, or spermicide for contraception

               9. Internal vaginal use of any device or product (except tampons) in the 48 hours
                  prior to enrollment

          4. Urogenital infection or suspected infection within 14 days of enrollment including:
             symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis;
             or cervical infection, including N. gonorrhoeae, C. trachomatis, or mucopurulent
             cervicitis; syphilis; herpes simplex virus lesions, or other sores (Note: seropositive
             Herpes simplex virus without active lesions will not be excluded); acute pelvic
             inflammatory disease; urinary tract infection; recent exposure to a partner with N.
             gonorrhoeae, C. trachomatis, Trichomonas, syphilis, or nongonococcal urethritis.

          5. Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment

          6. As determined by the PI, has any significant uncontrolled active or chronic
             cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric,
             endocrine, respiratory, immunologic disorder or infectious disease

          7. Menses-like bleeding at the time of the Enrollment visit* or expected menses-like
             bleeding within 14 days of the Enrollment visit (*Women who have vaginal bleeding at
             the scheduled Enrollment Visit may return at a different date to be re-examined and
             possibly enrolled provided they are still within the screening window and meet all
             criteria.)

          8. Any condition that, in the opinion of the Investigator, would preclude provision of
             consent, make participation in the study unsafe, complicate interpretation of study
             outcome data, or otherwise interfere with achieving the study objectives
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction