Clinical trial: Optical Imaging and User Perception Study of Vaginal Gel (NCT01716000)

Eligibility criteria:
Inclusion Criteria:

          -  have had vaginal penetrative intercourse within the last 12 months

          -  have a regular menstrual cycle (between 24-35 days) and be able to record the day of
             onset of menses in a menstrual diary

          -  able to ambulate for 20 consecutive minutes after vaginal self-insertion of gel using
             an applicator

          -  willing to use a condom when engaging in sexual intercourse within 4 days before a
             study visit

          -  willing to avoid using any mechanical sex toy within 1 day before a study visit

          -  willing to use one of the following contraception methods if engaging in sexual
             intercourse during the length of participation in the study (hormonal contraceptive,
             tubal ligation, non-surgical procedure such as permanent transcervical sterilization,
             Fallopian tubes removed, partner vasectomy)

          -  able to provide informed consent

        Exclusion Criteria:

          -  pregnant, potentially pregnant, nursing, or trying to conceive

          -  allergic to latex, fluorescein, hydroxyethylcellulose, ascorbic acid, sodium citrate,
             citric acid

          -  using an intrauterine device (IUD)

          -  using depo-provera

          -  douching during the course of participation in the study

          -  had medical or cosmetic surgery involving the reproductive organs or genitals within
             the past 6 months

          -  have a gynecological infection or other condition requiring treatment, such as
             candidiasis, chlamydia trachomatis, trichomoniasis, HIV, herpes simplex virus (HSV),
             neisseria gonorrhea, symptomatic bacterial vaginosis, or syphilis

          -  currently enrolled in any other research studies involving the application of vaginal
             formulations

          -  employed or supervised by the study investigators

          -  have any other condition that, in the opinion of the study physician, would
             contraindicate participation in the study
Female
Accepts Healthy Volunteers
Subject must be at least 21 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