Clinical trial: Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers (NCT02932904)

Eligibility criteria:
Inclusion Criteria:

          1. Is sexually active and has been in a steady relationship and plans to remain in that
             relationship for the duration of the study.

          2. Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and
             Baseline Visits.

          3. If female, has a regular menstrual cycle.

          4. Has normal sexual functioning, as defined by a Changes in Sexual Functioning
             Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and
             Baseline Visits.

          5. If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months
             prior to the Baseline Visit and continues on the stable dose for the duration of the
             study.

        Exclusion Criteria:

          1. Has received vortioxetine and/or paroxetine in a previous clinical study or as a
             therapeutic agent.

          2. Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)
             antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any
             known sexually transmitted diseases.

          3. Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.

          4. Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.

          5. Has a known history of or currently has increased intraocular pressure or is at risk
             of acute narrow-angle glaucoma.

          6. Has a history of depression or any other psychiatric illness.

          7. Has a significant risk of suicide according to the investigator's clinical judgment,
             or has made a suicide attempt in the previous 6 months.

          8. Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual
             dysfunction.

          9. Has had a surgical or medical procedure on reproductive/genitourinary organs
             (excluding uncomplicated vasectomy and tubal ligation).

         10. If female, has polycystic ovarian syndrome.

         11. Has hypogonadism or has a free testosterone value outside the normal range at the
             Screening Visit that is indicative of hypogonadism.

         12. Has a thyroid-stimulating hormone (TSH) value outside the normal range at the
             Screening Visit that is deemed clinically significant by the investigator.
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 40 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? Contradiction