Clinical trial: Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women (NCT02875119)

Eligibility criteria:
Inclusion Criteria:

          -  1) Between 18 and 49 years of age (at screening), inclusive.

          -  2) Willing and able to provide written informed consent.

          -  3) Healthy, based on medical history, vital signs, physical examination, urinalysis,
             laboratory evaluations for genital infections and laboratory evaluations for
             hematology, liver and renal function.

          -  4) HIV-negative as determined by HIV ELISA test at screening.

          -  5) In the absence of the use of exogenous hormone(s), have a self-reported regular
             menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days
             between menses.

          -  6) Normal Pap test at screening. (Documentation of normal Pap test results within 12
             months prior to screening is also acceptable.)

          -  7) Agrees to use effective contraception for the duration of the trial. If hormonal
             contraception or intrauterine device (IUD)/ Intrauterine system (IUS) is being used,
             it must be have been used for at least 30 days prior to screening, with no planned
             change in method during the study. The following forms of contraception (per
             self-report) are permitted: same-sex relationship, male or female sterilization, oral
             contraceptives, contraceptive implant, contraceptive patch, IUS, IUD
             depo-medroxyprogesterone acetate (DMPA; Depo-Provera®).

          -  8) Willing to abstain from sexual intercourse/activity including receptive vaginal,
             oral, digital, and anal intercourse, and the use of any vaginal products including
             tampons, male and female condoms, contraceptive sponges, diaphragms, cervical caps,
             douches, lubricants, and vibrators/dildos; starting the Screening Visit (Visit 0)
             through the final safety visit (Visit 3/Day 8) in the OL period; and starting 48 hours
             before enrollment through the final safety visit (Visit 8/Day 21) in the randomized
             period

          -  9) Agrees to not participate in any other clinical research for the duration of this
             trial.

        Exclusion Criteria:

          -  1) History of or known sensitivity/allergy to any component of either study product.

          -  2) Currently pregnant or breast-feeding, or within 3 months of last pregnancy outcome.

          -  3) Participation in any other clinical research trial involving investigational or
             marketed products currently or within two months of participation prior to screening,
             including any trial of a spermicide, microbicide and/or drug.

          -  4) Known bleeding disorder that could lead to prolonged or continuous bleeding with
             biopsy.

          -  5) Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 3
             months. Note: Women with a history of condylomata or genital herpes who have been
             asymptomatic for at least six months may be considered for eligibility.

          -  6) Positive test for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), or
             Trichomonas vaginalis (TV) at screening.

          -  7) Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract
             infection (UTI) at screening. (Participants who test positive at initial screening may
             be treated and re-tested once, and reconsidered for screening).

          -  8) Presence of any clinically significant genital epithelial findings (e.g. abrasions,
             ulcerations, or lacerations, or vesicles) suspicious for STIs at screening.

          -  9) History of hysterectomy or menopause.

          -  10) Use of excluded contraceptive methods including Nuvaring®, condoms (male or
             female), contraceptive sponge, diaphragm, or cervical cap.

          -  11) History of gynecological surgery or procedure within past 2 months.

          -  12) History of uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction
             within the last 3 months, including unexplained break-through bleeding requiring
             sanitary protection.

          -  13) Known current drug abuse, including illicit drugs, or alcohol abuse.

          -  14) Abnormal finding on laboratory or physical examination or a social or medical
             condition which, in the opinion of the investigator, would make participation in the
             study unsafe or would complicate interpretation of data.

          -  15) Unable to comply with study requirements, including but not limited to, attending
             all study visits, using the gel as directed, observing abstinence throughout the study
             and use of allowable effective contraceptives.

          -  16) History of latex allergy.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 49 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