NCT01821001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

4.5 years

First QC Date

March 21, 2013

Last Update Submit

January 10, 2018

Conditions

Adenomyosis

Keywords

AdenomyosisDysmenorrheaAbnormal Uterine bleedingHeavy Menstrual BleedingMenorrhagia

Outcome Measures

Primary Outcomes (1)

  • Objective improvement of adenomyosis

    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)

    6 months

Secondary Outcomes (1)

  • Scores from questionnaires that assess the severity of symptoms from adenomyosis

    9 months

Study Arms (1)

Vaginal Bromocriptine

EXPERIMENTAL

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

Interventions

Vaginal BromocriptineDRUG

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

Also known as: Cycloset, Parlodel
Vaginal Bromocriptine

Eligibility Criteria

Age25 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

AdenomyosisDysmenorrheaMetrorrhagiaMenorrhagia

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsUterine HemorrhageHemorrhage

Intervention Hierarchy (Ancestors)

ErgotaminesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsErgolinesHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Elizabeth Stewart, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Zaraq Khan, MBBS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 29, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

US(1)