Clinical trial: Dose-response Effect of Alcohol Ingestion on Steroid Profile (NCT02869763)

Eligibility criteria:
Inclusion Criteria:

          -  Participants will be healthy women aged 18 to 55 years. Women will enter in studies at
             the follicular phase of the menstrual cycle, in order to avoid the interference of
             estrogens.

          -  Female subjects (if not postmenopausal) possessing regular menstrual cycle between 26
             and 32 days and willing to use effective methods of contraception through the study
             (sexual abstinence, vasectomized partner, sterilization, intrauterine device,
             double-barrier method).

          -  Clinical history and physical examination demonstrating no organic or psychiatric
             disorders.

          -  The ECG and general blood and urine laboratory tests performed before the study should
             be within normal ranges. Minor or occasional changes from normal ranges are accepted
             if, in the investigator's opinion, considering the current state of the art, they are
             not clinically significant, are not life-threatening for the subjects and do not
             interfere with the product assessment. These changes and their non-relevance will be
             justified in writing specifically.

          -  The body mass index (BMI=weigh/height2) will range from 18.5 to 29.9 kg/m2, and the
             weight from 50 to 100 kg.

          -  Understanding and accepting the study procedures and signing the informed consent.

          -  Agreeing to follow a diet free from ethanol in the 72 hours prior to the start of each
             session and until the end of the study.

          -  Subjects with social or recreational alcohol consumption, at least 3 standard
             drinks/week and subjects with experience in several drunkenness.

        Exclusion Criteria:

          -  Not meeting the inclusion criteria.

          -  History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive
             drugs.

          -  Having suffered any organic disease or major surgery in the three months prior to the
             study start.

          -  History of psychiatric disorders.

          -  Women presenting amenorrhea or who suffer from moderate to intense premenstrual
             syndrome. Female subjects using hormonal contraceptive hormones.

          -  Smokers of more than 20 cigarettes per day.

          -  Taking more than 30 g of alcohol a day

          -  Regular use of any drug in the month prior to the study sessions. The treatment with
             single or limited doses of symptomatic medicinal products in the week prior to the
             study sessions will not be a reason for exclusion if it is calculated that it has been
             cleared completely the day of the experimental session.

          -  Ingestion of vitamin supplements or antioxidants or nonsteroidal anti-inflammatory
             drugs in the two weeks preceding the study.

          -  Blood donation 8 weeks before or participation in other clinical trials with drugs in
             the previous 12 weeks.

          -  Subjects with intolerance or adverse reactions to ethanol.

          -  Subjects who have suffered a hospitalization caused by alcohol intoxication or who
             have received treatment for drunkenness

          -  History or clinical evidence of gastrointestinal, liver, renal or other disorders
             which may lead to suspecting a disorder in drug absorption, distribution, metabolism
             or excretion, or that suggest gastrointestinal irritation due to drugs.

          -  Subjects unable to understand the nature, consequences of the study and the procedures
             requested to be followed.

          -  Subjects with positive serology to Hepatitis B, C or HIV.

          -  Subjects who follow a vegetarian diet.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 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