Vaginal Bromocriptine for Treatment of Adenomyosis

Mayo Clinic1 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adenomyosis

Interventions

Vaginal BromocriptineDRUG

Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Objective improvement of adenomyosis

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)

Time frame: 6 months

Secondary Outcomes

Scores from questionnaires that assess the severity of symptoms from adenomyosis

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.

Time frame: 9 months

Data from ClinicalTrials.gov

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