Clinical Trial: Vaginal Bromocriptine for Treatment of Adenomyosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Vaginal Bromocriptine for the Treatment of Adenomyosis
Brief 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.
Detailed Summary: 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
Sponsor: Mayo Clinic
Current Primary Outcome: Objective improvement of adenomyosis [ Time Frame: 6 months ]
Original Primary Outcome: Objective improvement of adenomyosis [ Time Frame: 6 months ]
Current Secondary Outcome: Scores from questionnaires that assess the severity of symptoms from adenomyosis [ Time Frame: 9 months ]
Original Secondary Outcome: Scores from filled questionnaires that assess the severity of symptoms from adenomyosis [ Time Frame: 9 months ]
Information By: Mayo Clinic
Dates:
Date Received: March 21, 2013
Date Started: March 2013
Date Completion: December 2017
Last Updated: March 23, 2017
Last Verified: March 2017