A Phase 1 interventional study of Vaginal Bromocriptine in Adenomyosis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-01-12.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
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.
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
135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.
This study's enrollment of 1 is below the median of 100 across 73 interventional studies indexed under Adenomyosis.
Browse Adenomyosis studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.
Drug: Vaginal Bromocriptine
Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.
Also known as: Cycloset, Parlodel
Objective improvement of adenomyosis
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)
Time frame: 6 months
Scores from questionnaires that assess the severity of symptoms from adenomyosis
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.
Time frame: 9 months
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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