Vaginal Bromocriptine for Treatment of Adenomyosis

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Elizabeth Stewart, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20112065

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