Clinical trial: Effects of Caffeine on Women's Sexual Arousal (NCT01242046)

Eligibility criteria:
Inclusion Criteria:

          -  Women aged 18 or older

          -  Heterosexual

          -  Experiencing regular menstrual cycles (not more than 1 missed menstrual period in the
             past 6 months).

          -  Currently involved in a stable, sexually active relationship.

          -  Fluent in the English language.

        Exclusion Criteria:

          -  Self-report of sexual aversion or distress; or of distress related to a history of
             unwanted or coercive sexual contact.

          -  Perimenopausal or menopausal status, or >1 missed menstrual period in the previous 6
             months; or currently pregnant, breastfeeding, or having breastfed within the past 3
             months; or clinically significant untreated renal or endocrine disease.

          -  History of HIV infection or active, untreated pelvic, vaginal, or urinary tract
             infection including sexually transmitted diseases such as chlamydia, genital herpes,
             gonorrhea, or syphilis.

          -  Previous major pelvic surgery that may have caused nerve damage, including
             hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder,
             rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke,
             pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis,
             multiple sclerosis or spinal cord damage.

          -  Self-report of an untreated psychosis (e.g., bipolar disorder or schizophrenia).

          -  Women who do not use caffeine products regularly (i.e., on a daily basis).

          -  Women receiving any of the following medications will be excluded from the study, as
             they have been shown to alter sexual function or arousal response:
             Dehydroepiandrosterone (DHEA), testosterone and other androgens, estrogens (except
             oral contraceptives), progesterone, tamoxifen, raloxifene, and other selective
             estrogen receptor modulators (SERMs), Beta blockers or other drugs that affect the
             autonomic nervous system and/or cardiovascular system, any approved or experimental
             medications or treatments used to enhance the sexual response (e.g., sildenafil), and
             antidepressants
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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