Adenomyosis
Conditions
Keywords
Adenomyosis, Dysmenorrhea, Abnormal Uterine bleeding, Heavy Menstrual Bleeding, Menorrhagia
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
Interventions
Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective improvement of adenomyosis | 6 months | All patients will get a baseline imaging of the uterus with MRI and a brief procedure, similar to a pap smear, to obtain tissue from the uterus and also a blood draw. Patients will then receive vaginal bromocriptine twice daily and will be reassessed at 6 months with an MRI to see objective improvement in the extent of the disease. This 6 month visit is the only one that would require an in person visit to the research site (Mayo Clinic in this case) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores from questionnaires that assess the severity of symptoms from adenomyosis | 9 months | Patients will fill out questionnaires at 1, 3, 6 and 9 months. These questionnaires are validated for study of gynecologic diseases and assess the severity of symptoms in patients. |
Countries
United States
Outcome results
None listed