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Vaginal Bromocriptine for Treatment of Adenomyosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01821001
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Elizabeth A. Stewart, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenomyosis Drug: Vaginal Bromocriptine Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaginal Bromocriptine for the Treatment of Adenomyosis
Actual Study Start Date : March 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Objective improvement of adenomyosis [ Time Frame: 6 months ]
    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 :
  1. Scores from questionnaires that assess the severity of symptoms from adenomyosis [ Time Frame: 9 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes 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 opioid pain medications
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821001


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Elizabeth Stewart, MD Mayo Clinic
Principal Investigator: Zaraq Khan, MBBS Mayo Clinic
More Information
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Responsible Party: Elizabeth A. Stewart, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01821001    
Other Study ID Numbers: 11-007353
First Posted: March 29, 2013    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Keywords provided by Elizabeth A. Stewart, Mayo Clinic:
Adenomyosis
Dysmenorrhea
Abnormal Uterine bleeding
Heavy Menstrual Bleeding
Menorrhagia
Additional relevant MeSH terms:
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Adenomyosis
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Bromocriptine
Antiparkinson Agents
 Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action