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 ]

All patients will get a baseline imaging of the uterus with MRI and a brief procedure, similar to a pap smear, to obtain tissue from the uterus and also a blood draw. Patients will then receive vaginal bromocriptine twice daily and will be reassessed at 6 months with an MRI to see objective improvement in the extent of the disease. This 6 month visit is the only one that would require an in person visit to the research site (Mayo Clinic in this case)


Original Primary Outcome: Objective improvement of adenomyosis [ Time Frame: 6 months ]

All patients will get a baseline imaging of the uterus with MRI. Patients will then receive vaginal bromocriptine twice daily and will be reassessed at 6 months with an MRI to see objective improvement in the extent of the disease. This 6 month visit is the only one that would require an in person visit to the research site (Mayo Clinic in this case)


Current Secondary Outcome: Scores from questionnaires that assess the severity of symptoms from adenomyosis [ Time Frame: 9 months ]

Patients will fill out questionnaires at 1, 3, 6 and 9 months. These questionnaires are validated for study of gynecologic diseases and assess the severity of symptoms in patients.


Original Secondary Outcome: Scores from filled questionnaires that assess the severity of symptoms from adenomyosis [ Time Frame: 9 months ]

Patients will fill out questionnaires at 1, 3, 6 and 9 months. These questionnaires are validated for study of gynecologic diseases and assess the severity of symptoms in patients.


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