Clinical trial: Vaginal Bromocriptine for Treatment of Adenomyosis (NCT01821001)

Eligibility criteria:
Inclusion Criteria:

          1. Women able to give informed consent and willing and able to attend all study visits

          2. Premenopausal women at least 25 years of age

          3. No evidence of High Grade SIL by pap smears or HPV testing within institutional
             guidelines

          4. MRI or ultrasound imaging consistent or highly suggestive of adenomyosis

          5. Use of barrier contraception, sterilization or sexual abstinence

        Exclusion Criteria:

          1. Women actively trying for pregnancy, currently pregnant, less than six months
             postpartum or breastfeeding

          2. Uterine size > 20 weeks

          3. Active pelvic infection or current use of intrauterine contraceptive device

          4. Current use of GnRH agonists or antagonists, or contraceptive steroids

          5. MRI suggestive of malignant disease of uterus, ovary, or cervix

          6. Hypersensitivity to bromocriptine or ergot alkaloids

          7. History of gastrointestinal ulcers

          8. History of syncope, syncopal migraine or seizure

          9. Uncontrolled hypertension

         10. History of myocardial infarction, uncontrolled hypertension, heart valve disorder or
             cerebrovascular accident

         11. History of diabetes mellitus except gestational diabetes

         12. History of Parkinson's Disease

         13. History of psychosis

         14. History of pleural or pericardial effusion

         15. History of pulmonary fibrosis or thickening of the pleura

         16. History of lactose intolerance

         17. History of Reynaud's Disease

         18. Use of opioid pain medications
Female
No healthy subjects accepted to join the trial.
Subject must be at least 25 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? 0