Vaginal Bromocriptine for Treatment of Adenomyosis
Location:
Rochester, MN.
Trial status:
Open for Enrollment
Why is this study being done?
Women with adenomyosis proven with MRI will be considered for the intervention with bromocriptine. They will be reassessed at 1, 6 and 9 months. Patients will get a stipend for each visit they complete. The study will end for the enrolled subject at 9th month follow-up
Who is eligible to participate?
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 antidepressants
19. Use of opioid pain medications
Last updated:
5/6/2013
NCT ID:
NCT01821001
IRB Number:
11-007353