Clinical trial: A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea (NCT00855829)

Eligibility criteria:
Inclusion Criteria:

          1. Women aged 18-35 years

          2. Regular menstrual cycles (26-35 days); average duration of menstruation ≥5 days for
             the 4 months preceding the beginning of the trial.

          3. Dysmenorrhea pain score >50mm on a 100mm visual analog scale (VAS) for the maximum
             abdominal pain

          4. Analgesic use during every menstrual cycle

          5. Non-pregnant, with no intentions to get pregnant during the clinical trial

          6. Agrees not to use oral contraceptives or an intrauterine device (IUD) during the trial
             period

          7. Agrees not to use analgesics, except during permitted period (16:00-04:00 the next
             day, daily)

          8. Consents to the use of pads or other vaginal devices throughout the trial period

          9. Subject is able to comply with all the requirements of the study and agrees to
             participate in all the activities of the study

         10. Signed written informed consent form (ICF) to participate in the study

        Exclusion Criteria:

          1. Pregnant or lactating women

          2. Used hormonal and/or oral contraceptives in the preceding 4 months

          3. Use of an IUD in the preceding 4 months

          4. Previous diagnosis of secondary dysmenorrhea

          5. Urinary incontinence

          6. Duration of menstruation is <5 days

          7. Subjects with a known sensitivity to mechanical vibrations and/or silicone

          8. Participation in current or recent clinical trial within 30 days prior to baseline
             visit
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 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