Clinical trial: Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women (NCT00676026)

Eligibility criteria:
Inclusion Criteria:

          -  Women ages 18-45 and able to give voluntary written informed consent;

          -  Regular menstrual periods of 24-35 days in length;

          -  Body mass index 18.5 to 30 kg/m2;

          -  No past or present DSM-IV psychiatric or substance dependence diagnosis by structured
             diagnostic interview (SCID-NP); no substance abuse history within the previous 2
             years;

          -  Absence of mood symptoms across the menstrual cycle during one month of prospective
             daily ratings with the Daily Record of Severity of Problems (DRSP); the DRSP is based
             on the DSM-IV research criteria for premenstrual dysphoric disorder (PMDD) and has
             been used in numerous studies to confirm the presence or absence of significant
             premenstrual mood and behavioral difficulties;

          -  Must be willing and able to participate in at least three of the four challenge
             paradigms.

        Exclusion Criteria:

          -  Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.);

          -  Family history of first degree relative with an Axis I psychiatric or substance
             dependence disorder (excepting alcohol and nicotine) (per subject report);

          -  Current treatment with psychoactive medication;

          -  Diabetes controlled by means other than diet;

          -  Use of steroid contraceptives (any method involving hormones) within the previous 4
             months;

          -  Habitual consumption of more than 7 alcoholic drinks per week or more than 2 drinks on
             any particular occasion; must be willing to abstain from alcohol consumption for 48
             hours prior to each 1H-MRS scan;

          -  Implanted metallic devices.
Female
Accepts Healthy Volunteers
Subject must be at least 18 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