Clinical trial: DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis (NCT01942122)

Eligibility criteria:
Inclusion Criteria:

          -  Signed informed consent before any trial related activities

          -  Female of 18 - 50 years of age

          -  Subjects suspected with cystic endometriosis or adenomyosis confirmed by transvaginal
             ultrasonography (or transrectal ultrasonography for unmarried subjects)

          -  Presence of moderate or severe pain as shown by VAS score of at least 4 on at least
             one of the following pain: menstrual pain (dysmenorrhea), dyspareunia, non-menstrual
             pelvic pain, dysuria, dyschezia

          -  Occurrence of at least 3 last sequential menstrual cycles of 21 - 35 days duration
             prior to screening

        Exclusion Criteria:

          -  Pregnancy

          -  Patients with infertility who are willing to be pregnant

          -  Using hormonal contraception or other forms of hormonal therapy within the last 30
             days

          -  Being under therapy with systemic corticosteroids on a chronic or regular basis within
             the last 90 days

          -  History or presence of suspected malignancy abnormalities

          -  History of surgical treatment for endometriosis within 3 months prior to screening

          -  History of hysterectomy or oophorectomy

          -  Presence of clinical signs of sexually transmitted disease

          -  Presence of unexplained uterine or cervical bleeding

          -  Impaired liver function: serum ALT > 2.5 times upper limit of normal

          -  Impaired renal function: serum creatinine >= 1.5 times upper limit of normal

          -  Known or suspected allergy to similar products
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 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