Status:
COMPLETED
Vaginal Bromocriptine for Treatment of Adenomyosis
Lead Sponsor:
Mayo Clinic
Conditions:
Adenomyosis
Eligibility:
FEMALE
25-55 years
Phase:
PHASE1
Brief Summary
Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for adenomyosis is hys...
Detailed Description
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 complet...
Eligibility Criteria
Inclusion
- Women able to give informed consent and willing and able to attend all study visits
- Premenopausal women at least 25 years of age
- No evidence of High Grade SIL by pap smears or HPV testing within institutional guidelines
- MRI or ultrasound imaging consistent or highly suggestive of adenomyosis
- Use of barrier contraception, sterilization or sexual abstinence
Exclusion
- Women actively trying for pregnancy, currently pregnant, less than six months postpartum or breastfeeding
- Uterine size \> 20 weeks
- Active pelvic infection or current use of intrauterine contraceptive device
- Current use of GnRH agonists or antagonists, or contraceptive steroids
- MRI suggestive of malignant disease of uterus, ovary, or cervix
- Hypersensitivity to bromocriptine or ergot alkaloids
- History of gastrointestinal ulcers
- History of syncope, syncopal migraine or seizure
- Uncontrolled hypertension
- History of myocardial infarction, uncontrolled hypertension, heart valve disorder or cerebrovascular accident
- History of diabetes mellitus except gestational diabetes
- History of Parkinson's Disease
- History of psychosis
- History of pleural or pericardial effusion
- History of pulmonary fibrosis or thickening of the pleura
- History of lactose intolerance
- History of Reynaud's Disease
- Use of opioid pain medications
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01821001
Start Date
March 1 2013
End Date
January 1 2018
Last Update
January 12 2018
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905