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NCT01821001 · ClinicalTrials.gov registry record · Phase 1
Vaginal Bromocriptine for Treatment of Adenomyosis
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT01821001: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT01821001 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01821001, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- DRUG Vaginal Bromocriptine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-03 |
| Est. Completion | 2018-01 |
| Phase | Phase 1 |
What the finished NCT01821001 record still lists
NCT01821001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Vaginal Bromocriptine is the first listed.
NCT01821001 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01821001 about?
NCT01821001 is a clinical study titled "Vaginal Bromocriptine for 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 anima...
What is the current status of trial NCT01821001?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2013-03. Estimated completion is 2018-01.
What interventions are being tested in trial NCT01821001?
The interventions under investigation include: Vaginal Bromocriptine (DRUG).
Who is sponsoring clinical trial NCT01821001?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01821001's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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