Vaginal Bromocriptine for Treatment of Adenomyosis

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Adenomyosis
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Brief Title

Vaginal Bromocriptine for Treatment of Adenomyosis

Official Title

Vaginal Bromocriptine for the Treatment of Adenomyosis

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

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Objective improvement of adenomyosis

Secondary Outcome

 Scores from questionnaires that assess the severity of symptoms from adenomyosis

Condition

Adenomyosis

Intervention

Vaginal Bromocriptine

Study Arms / Comparison Groups

 Vaginal Bromocriptine
Description:  Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

1

Start Date

March 2013

Completion Date

January 2018

Primary Completion Date

September 2017

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

Gender

Female

Ages

25 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Elizabeth Stewart, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01821001

Organization ID

11-007353

Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic

Study Sponsor

Elizabeth Stewart, MD, Principal Investigator, Mayo Clinic

Verification Date

January 2018