AdenomyosisPhase 1NCT01821001
Vaginal Bromocriptine for Treatment of Adenomyosis
A Phase 1 study testing Vaginal Bromocriptine in people with Adenomyosis, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Vaginal Bromocriptine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jan 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Vaginal Bromocriptine for the 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.
Read the 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
- Being tested
- Vaginal Bromocriptine
- Keywords
- Adenomyosis, Dysmenorrhea, Abnormal Uterine bleeding, Heavy Menstrual Bleeding, Menorrhagia
- Medical subject headings
- Adenomyosis, Dysmenorrhea, Metrorrhagia, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal BromocriptineDrug
Also called Cycloset, Parlodel
Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vaginal Bromocriptine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth A. Stewart, Mayo Clinic
- Investigators
- Elizabeth Stewart, MD, Principal investigator, Mayo ClinicZaraq Khan, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821001
- Sponsor's protocol ID
- 11-007353
- Status last verified
- Jan 2018
- First submitted
- 21 Mar 2013
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Bromocriptine for the Treatment of Adenomyosis
- ClinicalTrials.gov ID
- NCT01821001
- Acronym / sponsor ID
- 11-007353
- Conditions
- Adenomyosis
- Keywords
- Adenomyosis, Dysmenorrhea, Abnormal Uterine bleeding, Heavy Menstrual Bleeding, Menorrhagia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal Bromocriptine | Experimental | Drug: Vaginal BromocriptinePatients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal BromocriptineAlso: Cycloset, ParlodelPatients 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 |
Primary outcome
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)
1 secondary outcome
Scores from questionnaires that assess the severity of symptoms from adenomyosis
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
Related trials for Adenomyosis
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Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
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Linzagolix in Adenomyosis and Recurrent Implantation Failure
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Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
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Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Stewart, MD principal investigator
Mayo Clinic
Zaraq Khan, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaginal Bromocriptine in people with Adenomyosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective improvement of adenomyosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.