Clinical trial NCT01821001: Vaginal Bromocriptine for Treatment of Adenomyosis
Official title: Vaginal Bromocriptine for the Treatment of Adenomyosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenomyosis
Keywords: Adenomyosis
Dysmenorrhea
Abnormal Uterine bleeding
Heavy Menstrual Bleeding
Menorrhagia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 1
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
measure: Objective improvement of adenomyosis
timeFrame: 6 months
Secondary outcomes:
measure: Scores from questionnaires that assess the severity of symptoms from adenomyosis
timeFrame: 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Elizabeth Stewart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Zaraq Khan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: