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Vaginal Bromocriptine for Treatment of Adenomyosis

Primary Purpose

Adenomyosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vaginal Bromocriptine

About this trial

This is an interventional treatment trial for Adenomyosis focused on measuring Adenomyosis, Dysmenorrhea, Abnormal Uterine bleeding, Heavy Menstrual Bleeding, Menorrhagia

Eligibility Criteria

25 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaginal Bromocriptine

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Scores from questionnaires that assess the severity of symptoms from adenomyosis

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.

Full Information

NCT ID

NCT01821001

First Posted

March 21, 2013

Last Updated

January 10, 2018

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01821001

Brief Title

Vaginal Bromocriptine for Treatment of Adenomyosis

Official Title

Vaginal Bromocriptine for the Treatment of Adenomyosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

March 2013 (Actual)

Primary Completion Date

September 2017 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenomyosis

Keywords

Adenomyosis, Dysmenorrhea, Abnormal Uterine bleeding, Heavy Menstrual Bleeding, Menorrhagia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaginal Bromocriptine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vaginal Bromocriptine

Other Intervention Name(s)

Cycloset, Parlodel

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective improvement of adenomyosis

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Scores from questionnaires that assess the severity of symptoms from adenomyosis

Description

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.

Time Frame

9 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Stewart, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zaraq Khan, MBBS

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Vaginal Bromocriptine for Treatment of Adenomyosis

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