Clinical trial: Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms (NCT02569697)

Eligibility criteria:
Volunteers must meet all of the following criteria prior to genital sampling at Visit 2:

          -  Age 18 to 50 years, inclusive

          -  General good health (by volunteer history and per investigator judgment) without any
             clinically significant systemic disease (including, but not limited to significant
             liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease,
             osteoporosis or bone disease, and diabetes)

          -  History of Pap smears and follow-up consistent with standard medical practice as
             outlined in the Study Manual or willing to undergo a Pap smear at V1

          -  Willing to give voluntary consent and sign an informed consent form

          -  Willing and able to comply with protocol requirements

          -  Protected from pregnancy by:

               -  hysterectomy

               -  reliable methods of contraception other than male or female condoms,
                  contraceptive IVR or male partner's vasectomy

               -  abstinence (IVR group only)

               -  or in a same sex relationship (IVR group only)

          -  For gel, insert or film assigned participants: Willing to engage in intercourse with a
             male sexual partner without the use of male or female condoms as required in the
             protocol

          -  For gel, insert or film assigned participants: In a mutually monogamous relationship
             with a male partner who:

               -  Is at least 18 years old

               -  Is not known to be HIV positive

               -  Has no known risk for STIs

               -  Has not undergone a vasectomy

               -  Is not known to have azoospermia

               -  Is willing and able to comply with protocol requirements regarding sexual
                  activity/ abstinence

               -  Can engage with the participant in vaginal intercourse without condoms, as
                  specified in the protocol 8.2. Exclusion Criteria

        Volunteers must not meet any of the following criteria prior to genital sampling at Visit
        2:

          -  Currently pregnant

          -  Currently breastfeeding or planning to breastfeed during the course of the study

          -  History of sensitivity/allergy to any component of the vaginal products for either the
             volunteer or her sexual partner, as applicable

          -  Use of vaginal douches, creams or gels, other than the study product, at any time
             during the study, beginning 7 days prior to V2

          -  In the last six months, either the volunteer or her sexual partner (as applicable)
             diagnosed with or treated for any STI. Note: Women with a history of genital herpes
             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

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

          -  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

          -  Abnormal finding on laboratory or physical examination or a social or medical
             condition in either the volunteer or her sexual partner (as applicable) 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 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