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Completed

NCT Number: NCT01821001

Vaginal Bromocriptine for Treatment of Adenomyosis

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.

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Key information

Conditions

Adenomyosis Dysmenorrhea Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Metrorrhagia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women able to give informed consent and willing and able to attend all study visits
  • Premenopausal women at least 25 years of age
  • No evidence of High Grade SIL by pap smears or HPV testing within institutional guidelines
  • MRI or ultrasound imaging consistent or highly suggestive of adenomyosis
  • Use of barrier contraception, sterilization or sexual abstinence

Exclusion criteria

  • Women actively trying for pregnancy, currently pregnant, less than six months postpartum or breastfeeding
  • Uterine size > 20 weeks
  • Active pelvic infection or current use of intrauterine contraceptive device
  • Current use of GnRH agonists or antagonists, or contraceptive steroids
  • MRI suggestive of malignant disease of uterus, ovary, or cervix
  • Hypersensitivity to bromocriptine or ergot alkaloids
  • History of gastrointestinal ulcers
  • History of syncope, syncopal migraine or seizure
  • Uncontrolled hypertension
  • History of myocardial infarction, uncontrolled hypertension, heart valve disorder or cerebrovascular accident
  • History of diabetes mellitus except gestational diabetes
  • History of Parkinson's Disease
  • History of psychosis
  • History of pleural or pericardial effusion
  • History of pulmonary fibrosis or thickening of the pleura
  • History of lactose intolerance
  • History of Reynaud's Disease
  • Use of opioid pain medications

Treatment and study plan

Vaginal Bromocriptine

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Vaginal Bromocriptine for the Treatment of Adenomyosis

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Mar 29, 2013
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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