NCT01821001

Vaginal Bromocriptine for Treatment of Adenomyosis

Vaginal Bromocriptine for the Treatment of Adenomyosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Adenomyosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2017-09-01
• Completion: 2018-01-01
• First posted: 2013-03-29
• Last updated: 2018-01-12

Locations

1 site across 1 country: United States