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Vaginal Bromocriptine for Treatment of Adenomyosis

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adenomyosis

Intervention: Vaginal Bromocriptine (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Elizabeth Stewart, MD, Principal Investigator, Affiliation: Mayo Clinic
Zaraq Khan, MBBS, Principal Investigator, Affiliation: Mayo Clinic


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.

Clinical Details

Official title: Vaginal Bromocriptine for the Treatment of Adenomyosis

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Objective improvement of adenomyosis

Secondary outcome: Scores from questionnaires that assess the severity of symptoms from adenomyosis

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


Minimum age: 25 Years. Maximum age: 55 Years. Gender(s): Female.


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 and Contacts

Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States
Additional Information

Starting date: March 2013
Last updated: January 21, 2015

Page last updated: August 23, 2015

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