Clinical trial: Safety Study of UC-781 Vaginal Microbicide (NCT00446979)

Eligibility criteria:
Inclusion Criteria for women:

          -  Age 18-50 years old

          -  Regular menses

          -  HIV-1 seronegative at screening

          -  Normal Pap smear at screening or documented normal Pap smear within six months prior
             to screening

          -  No evidence of reproductive tract infection (RTI)

          -  Willing and able to comply with study procedures, including pelvic exams, colposcopy,
             maintaining a study coital and symptom log, and applying assigned study gel per
             protocol

          -  Agree to abstain from sexual intercourse for 24 hours prior to the enrollment visit

          -  Agree to abstain from the following activities from at least 48 hours prior to
             enrollment through the Day 14 visit:

               -  Insertion of fingers and other objects into the vagina

               -  Receiving oral sex

               -  Receiving anal sex

               -  Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring

               -  Using vaginal products other than the study gels, including douches, lubricants,
                  or feminine hygiene products

          -  In a monogamous sexually active relationship with one male partner

          -  Report having vaginal intercourse only with that partner at least two times per week

          -  No other reported partner in the prior six months and no plan to have another partner
             for the duration of the study

          -  Agree to use condoms for each act of vaginal intercourse during participation in the
             study

          -  Their male partner is informed and also consents to participate in the study

          -  Willing to have male partner informed and treated if an STD is diagnosed at screening
             or during the study

        Inclusion Criteria for men:

          -  Age 18 years or older

          -  HIV-seronegative and free of other STI at screening exam

          -  One female sexual partner; no other reported partner in the prior six months and no
             plan to have another partner for the duration of the study

          -  Willing and able to comply with study procedures, including clinic visits, interviews
             and acceptability evaluation, and consistent use of condoms during enrollment in the
             study

          -  Willing to have female partner informed and treated if an STD is diagnosed at
             screening or during the study

        Exclusion Criteria for women:

          -  Pregnancy or desire to become pregnant at time of study participation

          -  Currently breastfeeding

          -  Delivery or abortion within last eight weeks

          -  History of any male sexual partner other than current partner in past six months

             - No abnormal (DAIDS grade 1 or higher) laboratory results at baseline, including
             hematology, liver and kidney function

          -  History of post-coital vaginal bleeding in the past three months

          -  History of surgery to remove uterus or cervix

          -  History of surgery on the external genitalia, vaginal, or cervix in the past month

          -  Clinically significant chronic medical condition that is considered progressive,
             including cardiopulmonary disease, renal disease, hepatic disease, diabetes mellitus.

          -  History of sensitivity/allergy to latex

          -  Existence of a clinically detectable genital abnormality at screening (e.g. ulcer,
             congenital abnormality, any lesion with mucosal disruption)

          -  Concurrent participation in another trial of a vaginal product

          -  Have any other condition that in the opinion of the investigator might interfere with
             the evaluation of the study objectives

        Exclusion Criteria for men:

          -  History of genital surgery in the past month

          -  Clinical or laboratory evidence of an STI.

          -  History of sensitivity/allergy to latex

          -  History of any sexual partner other than their current partner in the past six months
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 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