Vaginal Bromocriptine for Treatment of Adenomyosis

This study is currently recruiting participants.
Verified November 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Elizabeth A. Stewart, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01821001
First received: March 21, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Adenomyosis
Drug: Vaginal Bromocriptine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaginal Bromocriptine for the Treatment of Adenomyosis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Objective improvement of adenomyosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Scores from questionnaires that assess the severity of symptoms from adenomyosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 33
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 antidepressants
  19. Use of opioid pain medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01821001

Contacts
Contact: Kristi L Allen, RN 507-293-3446 allen.kristi1@mayo.edu
Contact: Zaraq Khan, MBBS khan.zaraq@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kristi L Allen, RN    507-293-3446    allen.kristi1@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Elizabeth Stewart, MD Mayo Clinic
Principal Investigator: Zaraq Khan, MBBS Mayo Clinic
  More Information

No publications provided

Responsible Party: Elizabeth A. Stewart, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01821001     History of Changes
Other Study ID Numbers: 11-007353
Study First Received: March 21, 2013
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Adenomyosis
Dysmenorrhea
Abnormal Uterine bleeding
Heavy Menstrual Bleeding
Menorrhagia

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Bromocriptine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014