Clinical trial: Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products (NCT02534779)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18-50 years, inclusive

          -  General good health (by volunteer history and investigator judgment)

          -  Currently having regular menstrual cycles of 21 - 35 days by volunteer report

          -  Protected from pregnancy, meaning one of the following: Sexually abstinent and
             planning to remain abstinent for the duration of the study; In a monogamous
             heterosexual relationship for at least four months with a partner who is not known to
             be HIV positive and has no known risks for sexually transmitted infections (STIs) and:
             Couple is using condoms and is willing to use non-spermicidally lubricated condoms
             throughout the study or One partner is sterilized; or in a monogamous same-sex
             relationship for at least four months with a partner who is not known to be HIV
             positive and has no known risks for STIs.

          -  Willing to abstain from vaginal activity and vaginal product use as required in the
             protocol

          -  Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
             easy examination

          -  Willing to give voluntary consent, sign an informed consent form and comply with study
             procedures as required by the protocol

        Exclusion Criteria:

          -  History of hysterectomy

          -  Currently pregnant or within two calendar months from the last pregnancy outcome.
             Note: If recently pregnant must have had at least two spontaneous menses since
             pregnancy outcome

          -  Use of any hormonal contraceptive method in the last 30 days (oral, transdermal,
             transvaginal, implant, or hormonal intrauterine contraceptive device)

          -  Injection of Depo-Provera in the last 6 months

          -  Current use of copper intrauterine device (IUD)

          -  Currently breastfeeding or having breastfed an infant in the last two months, or
             planning to breastfeed during the course of the study

          -  History of sensitivity/allergy to any component of the study products

          -  Symptomatic reproductive tract infection (RTI)

          -  Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)

          -  Known current drug or alcohol abuse which could impact study compliance

          -  Participation in any other investigational trial (device, drug, or vaginal trial)
             within the last 30 days or planned participation in any other investigational trial
             during the study

          -  History of gynecological procedures (including genital piercing) on the external
             genitalia, vagina or cervix within the last 14 days

          -  Abnormal finding on 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
Female
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