Clinical trial: Expression of IFN-epsilon in the Female Reproductive Tract (NCT02416154)

Eligibility criteria:
Inclusion Criteria:

          1. Age 18 through 35 years (inclusive) at screening

          2. Non-pregnant women in general good health as determined by the site clinician

          3. Premenopausal with history of regular menstrual cycles (regular cycles defined as
             occurring every 21-35 days when not using hormones and with a variation of typical
             cycle length of no more than 5 days)

          4. Regular and consistent condom use, prior surgical sterilization by participant or
             sexual partner, or heterosexually abstinent since last menses prior to enrollment

          5. Able and willing to provide written informed consent to be screened for and to take
             part in the study, including willingness to undergo all study-related assessments and
             follow all study-related procedures

          6. Able and willing to provide adequate locator information

          7. HIV-uninfected based on testing performed by study staff at enrollment

        Exclusion Criteria:

          1. Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment

          2. Use of depot medroxyprogesterone acetate (DMPA) within 10 months of enrollment

          3. Pregnancy or breastfeeding within 60 days of enrollment

          4. Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes
             dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and
             endometrium)

          5. Internal vaginal use of any device (includes sex toys, cervical caps, diaphragms,
             menstrual collection devices, and pessaries; excludes tampons and condoms) or product
             (includes spermicide, microbicide, douche, antifungal, steroid, or hormone) in the 30
             days prior to enrolment (includes investigational products and devices)

          6. New sexual partner within 90 days of enrollment

          7. Urogenital infection or suspected infection within 30 days of enrollment including:
             symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis;
             or cervical infection, including N. gonorrhoea (GC), C. trachomatis (CT), or
             mucopurulent cervicitis; syphilis; herpes simplex virus (HSV) lesions, or other sores
             (Note: seropositive HSV without active lesions will not be excluded); acute pelvic
             inflammatory disease; urinary tract infection; recent exposure to a partner with GC,
             CT, Trichomonas, syphilis, or non-gonococcal urethritis (NGU)

          8. Any history of immunosuppression (includes diabetes, HIV infection, and chronic
             steroid use or other immunosuppressive medications)

          9. Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment

         10. Menses or other vaginal bleeding at the time of enrollment* (*Women who have vaginal
             bleeding at the scheduled enrollment visit may return at a different date to be
             re-examined and possibly enrolled provided they are still within the 90-day screening
             window and meet all criteria).

         11. Vaginal or anal intercourse within 36 hours prior to enrollment

         12. Heterosexual intercourse since last menses that places the participant at risk of
             pregnancy (without condom use or sterilization of at least one partner)

         13. History of hysterectomy

         14. History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)

         15. Any condition that, in the opinion of the Investigator, would preclude provision of
             consent, make participation in the study unsafe, complicate interpretation of study
             outcome data, or otherwise interfere with achieving the study objectives
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 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