Vaginal Bromocriptine for Treatment of Adenomyosis

checkorphan
Learn more about:
Adenomyosis
Related Clinical Trial
The Use of Shear Wave Elastography, Transvaginal Ultrasound and Pelvic MRI in the Diagnosis of Adenomyosis Long-term Use of Mifepristone in the Treatment of Adenomyosis Radiofrequency Ablation of Adenomyosis Determination of the Incidence of Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome, or the Incidence of Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis The Effect of Adenomoyosis on Pregnancy Outcomes Observational Study of Patients Suffering From Endometriosis and Adenomyosis Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis Quality of Life After Hysterectomy (AdenoQOL) Low Molecular Weight Heparin on the Adenomyosis Patients’IVF-ET Outcome Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI Clinical and Molecular Study of Endometriosis and Adenomyosis Surgical Success After Laparoscopic vs Abdominal Hysterectomy Electronic Catheter Stethoscope Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? Single-port Access Laparoscopic-assisted Vaginal Hysterectomy Uterine Artery Embolization for Symptomatic Fibroids Oxytocin in MRI-HIFU To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy Effect of Addition of Steroids on Duration of Analgesia Paracervical Block in Laparoscopic Hysterectomy Use of Dexamethasone in Uterine Artery Embolization Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU) Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS) Dienogest for Treatment of Adenomyotic Uteri Health-Related QoL Among Women Receiving Hysterectomy in NTUH Development and Validation of EHP-30 (Hong Kong Chinese Version) for Patients With Endometriosis and Adenomyosis Adenomyosis and Ulipristal Acetate Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis LNG-IUS for Treatment of Dysmenorrhea Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis Adenomyosis: Genomic Mechanisms and Biological Response What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis A Prospective Study of Diagnostic Accuracy of Ultrasound Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis A Multi-omics Study of Adenomyosis Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis Levonorgestrel Intrauterine System and Adenomyosis Validation of the Adenomyosis Calculator Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer. New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis Norwegian Adenomyosis Study III: Peristalsis Histopathological Diagnosis of Adenomyosis Norwegian Adenomyosis Study I Vaginal Bromocriptine for Treatment of Adenomyosis Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

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