Clinical trial: Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation (NCT01593124)

Eligibility criteria:
Inclusion Criteria:

          1. 21 to 45 years of age, inclusive;

          2. In good health, as evidenced by history and procedures at screening and enrollment
             visits without any clinically significant systemic disease;

          3. Not be at risk for pregnancy, due to surgical sterilization of participant and or her
             sexual partner, abstinence for duration of study, consistent condom use, non-hormonal
             IUD or same sex relationship. Note: If consistent condom user, must agree to use
             condoms without spermicide for duration of study.;

          4. Have had regular menstrual cycles (every 24-35 days) for the past two cycles;

          5. Willing and able to comply with study procedures

        Exclusion Criteria:

          1. A clinically significant history of an abnormal pap smear (by written report) that has
             not been evaluated and or treated, if indicated, according to standard guidelines;

          2. It has been less than 9 months since the participant's last depot medroxyprogesterone
             acetate (DMPA) injection and she has not had 2 normal, spontaneous menses (this can be
             shortened to 6 months if the participant has had at least 2 normal spontaneous
             menses);

          3. Use of any other hormonal contraceptive method within past 3 months (oral,
             transdermal, transvaginal, implant, or intrauterine device) without 2 subsequent,
             normal menses;

          4. Surgery or biopsy of the vulva, vagina, or cervix (including piercings) within 30
             days;

          5. Pregnancy within the past 3 months;

          6. Currently breastfeeding;

          7. Current STI or lower genital tract infection (including, but not limited to HIV-1,
             HSV-2, Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Neisseria Protocol #
             D11-119 Version 2.0 April 13, 2012 10 gonorrhea (NG), Hepatitis B, high risk HPV sub
             types and or Syphilis), yeast vaginitis or bacterial vaginosis (BV);

          8. Current use of chronic immunosuppressants (for example daily steroids or daily
             non-steroidal anti-inflammatory drugs [NSAIDs]);

          9. Current presence of vulvar, anal and or vaginal genital warts;

         10. Current tobacco use of any amount;

         11. Other conditions that, in the opinion of the investigator, would constitute
             contraindications to participation in the study or would compromise the ability to
             comply with study protocols, such as any major chronic illness including but not
             limited to cancer, serious autoimmune disease, metabolic disorders or a major
             psychiatric disorder (e.g., schizophrenia); and

         12. Current participation in any other drug or device study, or any study which, in the
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Entailment