Vaginal Bromocriptine for Treatment of Adenomyosis

Study Overview
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Brief Summary
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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
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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

Official Title
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Vaginal Bromocriptine for the Treatment of Adenomyosis

Conditions
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Adenomyosis

Intervention / Treatment
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* Drug: Vaginal Bromocriptine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Bromocriptine<br>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<br>* Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.<br>* Other names: Parlodel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenomyosis, Dysmenorrhea, Abnormal Uterine bleeding, Heavy Menstrual Bleeding, Menorrhagia