Clinical trial: An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film (NCT04731818)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18 - 50 years, inclusive

          -  General good health, by volunteer history and per investigator judgment

          -  History of regular menstrual cycles of 21 - 35 days (inclusive), by volunteer report

          -  History of a normal PAP smear or ASCUS with negative HPV testing within the previous
             12 months

          -  Willing to abstain from intercourse and use of vaginal medications, lubricants, and
             other products as required in the protocol

          -  Willing to use non-spermicidal, lubricated condoms for any vaginal intercourse from
             the first day of each menstrual cycle until 72 hours before expected midcycle

          -  In a mutually monogamous relationship with a male partner who:

               -  Is at least 18 years old

               -  Has no known risk for sexually transmitted infections (STIs)

               -  Is willing and able to comply with protocol requirements including sexual
                  activity/ abstinence and condom use requirements

               -  Can engage in vaginal intercourse with the participant, with and without condoms,
                  as specified in protocol

          -  Protected from pregnancy by female surgical sterilization

          -  Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
             easy genital tract sample collection

          -  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

          -  Surgical sterility or known history of infertility in male partner

          -  Sterility or known history of sperm dysfunction in male partner

          -  Currently pregnant by urine pregnancy test at the enrollment visit, 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

          -  Current use of any hormonal contraceptive or a copper or hormonal IUD, or use of
             Depo-Provera in the last 120 days

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

          -  Significant gynecological abnormalities (including abnormal vaginal bleeding,
             excessive vaginal discharge, or vulvar/vaginal pain or irritation)

          -  Current UTI, vaginal candidiasis, or symptomatic bacterial vaginosis

          -  History of sensitivity/allergy to ZB-06 film components, for either the volunteer or
             her male partner

          -  In the last three months, either the volunteer or her male partner diagnosed with or
             treated for any STI or pelvic inflammatory disease, or either partner with known risk
             factors for sexually transmitted infections. Note: Women with a history of genital
             herpes or condylomata who have been asymptomatic for at least six months may be
             considered for eligibility

          -  Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
             or HIV at the screening visit

          -  Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or
             vesicles suspicious for an STI

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

          -  Participation in any other investigational 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 laboratory or physical examination or a social or medical
             condition in either the volunteer or her male partner which, in the opinion of the
             investigator, would make participation in the study unsafe or would complicate
             interpretation of data
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