Vaginal Bromocriptine for Treatment of Adenomyosis

Vaginal Bromocriptine for the Treatment of Adenomyosis

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.

Study Overview

• Status: Completed
• Conditions: Adenomyosis
• Intervention / Treatment: Drug: Vaginal Bromocriptine

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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Cycloset; Parlodel

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Zaraq Khan, MBBS, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: March 21, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): March 29, 2013

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Dysmenorrhea; Adenomyosis; Menorrhagia; Heavy Menstrual Bleeding; Abnormal Uterine bleeding
• Additional Relevant MeSH Terms: Uterine Diseases; Adenomyosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Dopamine Agonists; Dopamine Agents; Hormone Antagonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Bromocriptine
• Other Study ID Numbers: 11-007353