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Vaginal Bromocriptine for Treatment of Adenomyosis

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Elizabeth Stewart, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20112065

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