Brief Title
Vaginal Bromocriptine for Treatment of Adenomyosis
Official Title
Vaginal Bromocriptine for the Treatment of Adenomyosis
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 hysterectomy. The investigators will use a dopamine agonist, bromocriptine, as a therapy based on animal models of the disease and our prior clinical research to observe any objective improvement in the extent of the disease using Magnetic Resonance Imaging (MRI)and standard measurements for other gynecologic diseases to measure symptomatology.
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 complete. The study will end for the enrolled subject at 9th month follow-up
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Objective improvement of adenomyosis
Secondary Outcome
Scores from questionnaires that assess the severity of symptoms from adenomyosis
Condition
Adenomyosis
Intervention
Vaginal Bromocriptine
Study Arms / Comparison Groups
Vaginal Bromocriptine
Description: Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1
Start Date
March 2013
Completion Date
January 2018
Primary Completion Date
September 2017
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
Gender
Female
Ages
25 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
Elizabeth Stewart, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01821001
Organization ID
11-007353
Responsible Party
Principal Investigator
Study Sponsor
Mayo Clinic
Study Sponsor
Elizabeth Stewart, MD, Principal Investigator, Mayo Clinic
Verification Date
January 2018