Vaginal Bromocriptine for Treatment of Adenomyosis

Adenomyosis Clinical Trial

Official title:

Vaginal Bromocriptine for the Treatment of Adenomyosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821001
• Other study ID #: 11-007353
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2013
• Last updated: January 10, 2018
• Start date: March 2013
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	9 months