Vaginal Bromocriptine for Treatment of Adenomyosis

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Bromocriptine

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