Vaginal Bromocriptine for Treatment of Adenomyosis
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adenomyosis
Intervention: Vaginal Bromocriptine (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Elizabeth Stewart, MD, Principal Investigator, Affiliation: Mayo Clinic
Zaraq Khan, MBBS, Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Vaginal Bromocriptine for the Treatment of Adenomyosis
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Objective improvement of adenomyosis
Secondary outcome: Scores from questionnaires that assess the severity of symptoms from adenomyosis
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
Eligibility
Minimum age: 25 Years.
Maximum age: 55 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Women able to give informed consent and willing and able to attend all study visits
2. Premenopausal women at least 25 years of age
3. No evidence of High Grade SIL by pap smears or HPV testing within institutional
guidelines
4. MRI or ultrasound imaging consistent or highly suggestive of adenomyosis
5. Use of barrier contraception, sterilization or sexual abstinence
Exclusion Criteria:
1. Women actively trying for pregnancy, currently pregnant, less than six months
postpartum or breastfeeding
2. Uterine size > 20 weeks
3. Active pelvic infection or current use of intrauterine contraceptive device
4. Current use of GnRH agonists or antagonists, or contraceptive steroids
5. MRI suggestive of malignant disease of uterus, ovary, or cervix
6. Hypersensitivity to bromocriptine or ergot alkaloids
7. History of gastrointestinal ulcers
8. History of syncope, syncopal migraine or seizure
9. Uncontrolled hypertension
10. History of myocardial infarction, uncontrolled hypertension, heart valve disorder or
cerebrovascular accident
11. History of diabetes mellitus except gestational diabetes
12. History of Parkinson's Disease
13. History of psychosis
14. History of pleural or pericardial effusion
15. History of pulmonary fibrosis or thickening of the pleura
16. History of lactose intolerance
17. History of Reynaud's Disease
18. Use of opioid pain medications
Locations and Contacts
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States
Additional Information
Starting date: March 2013
Last updated: January 21, 2015
|
