Vaginal Bromocriptine for Treatment of Adenomyosis

NCT ID: NCT01821001

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2018-01-31

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

Conditions

Adenomyosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaginal Bromocriptine

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

Group Type: EXPERIMENTAL

Vaginal Bromocriptine

Intervention Type: DRUG

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

Interventions

Vaginal Bromocriptine

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

Other Intervention Names

Cycloset; Parlodel

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth A. Stewart

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Zaraq Khan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

11-007353

Identifier Type: -

Identifier Source: org_study_id