Vaginal Bromocriptine for Treatment of Adenomyosis

Completed · Phase 1

Conditions studied: Adenomyosis

In brief

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.

Key facts

Study ID

NCT01821001

Run by

Mayo Clinic

People needed

1

Starts

2013-03-01

Expected to finish

2018-01-01

Last updated by the study team

2018-01-12

Who can join

Age: 25 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women able to give informed consent and willing and able to attend all study visits
• Premenopausal women at least 25 years of age
• No evidence of High Grade SIL by pap smears or HPV testing within institutional guidelines
• MRI or ultrasound imaging consistent or highly suggestive of adenomyosis
• Use of barrier contraception, sterilization or sexual abstinence

You may not qualify if…

• Women actively trying for pregnancy, currently pregnant, less than six months postpartum or breastfeeding
• Uterine size > 20 weeks
• Active pelvic infection or current use of intrauterine contraceptive device
• Current use of GnRH agonists or antagonists, or contraceptive steroids
• MRI suggestive of malignant disease of uterus, ovary, or cervix
• Hypersensitivity to bromocriptine or ergot alkaloids
• History of gastrointestinal ulcers
• History of syncope, syncopal migraine or seizure
• Uncontrolled hypertension
• History of myocardial infarction, uncontrolled hypertension, heart valve disorder or cerebrovascular accident
• History of diabetes mellitus except gestational diabetes
• History of Parkinson's Disease
• History of psychosis
• History of pleural or pericardial effusion
• History of pulmonary fibrosis or thickening of the pleura
• History of lactose intolerance
• History of Reynaud's Disease
• Use of opioid pain medications

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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