Clinical trial: To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea (NCT02617537)

Eligibility criteria:
Inclusion Criteria:

          -  Patients suffering from dysmenorrhea for at least the previous 3 months prior to Visit
             1 with a minimum visual analogue scale (VAS) score of 30 mm with regard to pain during
             the menstrual period of the screening period

          -  Good general health (except for findings related to dysmenorrhea) as proven by medical
             history

          -  Patients aged 18 years or older at the time of obtaining informed consent; smokers
             must not be older than 35 years at the time point of informed consent

          -  Normal or clinically insignificant cervical smear not requiring further follow up (a
             cervical smear has to be taken at screening visit or a normal result has to be
             documented within the previous six months). Human papilloma virus (HPV) testing in
             subjects with atypical squamous cells of undetermined significance (ASCUS) can be used
             as an adjunctive test. Subjects with ASCUS can be included if they are negative for
             high-risk HPV strains (HPV 16, HPV18).

          -  Women of childbearing potential must agree that adequate contraception will be used
             when they are sexually active. This applies from signing of the informed consent form
             until 2 weeks after the last study drug administration.

        Exclusion Criteria:

          -  Pregnancy (confirmed or suspected) or lactation (less than three months since
             delivery, abortion, or lactation before start of treatment)

          -  Patients who wish to become pregnant during the course of the study

          -  Body Mass Index (BMI) > 32 kg/m2

          -  Hypersensitivity to any ingredient of the study drug

          -  Laboratory values outside inclusion range before randomization

          -  Any diseases or conditions that can compromise the function of the body systems and
             could result in altered absorption, excessive accumulation, impaired metabolism, or
             altered excretion of the study medication

          -  Any diseases or conditions that might interfere with the conduct of the study or the
             interpretation of the results

          -  Any disease or condition that may worsen under hormonal treatment according to the
             assessment and opinion of the investigator.
Female
No healthy subjects accepted to join the trial.
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