Overview

This trial is active, not recruiting.

Condition adenomyosis
Treatment vaginal bromocriptine
Phase phase 1
Sponsor Mayo Clinic
Start date March 2013
End date March 2017
Trial size 33 participants
Trial identifier NCT01821001, 11-007353

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.
vaginal bromocriptine Cycloset
Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.

Primary Outcomes

Measure
Objective improvement of adenomyosis
time frame: 6 months

Secondary Outcomes

Measure
Scores from questionnaires that assess the severity of symptoms from adenomyosis
time frame: 9 months

Eligibility Criteria

Female participants from 25 years up to 55 years old.

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

Additional Information

Official title Vaginal Bromocriptine for the Treatment of Adenomyosis
Principal investigator Elizabeth Stewart, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.