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NCT01072136 · ClinicalTrials.gov registry record · Phase 3
Empiric Therapy of Mucopurulent Cervicitis (MPC)
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
NCT01072136: Clinical Trial Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01072136 is a Phase 3 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01072136, a Phase 3 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
Mucopurulent cervicitis (MPC) is a syndrome with associated symptoms including mucopurulent discharge (mucus and pus) from the cervix and other signs of inflammation such as easily induced cervical bleeding. The purpose of this study is to evaluate the effectiveness of no treatment versus empiric treatment with a single dose of cefixime and azithromycin for cure of MPC. Empiric treatment is the initiation of treatment prior to a firm diagnosis. Study participants will include 772 women ages 18 and older in good health with MPC. Women will be randomly assigned to 1 of 2 possible study groups: Group 1 will receive a single dose of cefixime and azithromycin antibiotics and Group 2 will receive placebo (inactive substance). Study procedures will include pelvic examination with a cervical swab sample. Participants will be involved in study related procedures for approximately 2 months, which includes 3 study visits.
Primary Outcome
The proportion of participants who have cleared MPC by the second follow-up visit. Clinical cure is defined as: absence of cervical mucopus and absence of easily induced cervical bleeding and \< 30 white blood cells per oil immersion field on cervical gram stain.
Interventions
- OTHER Placebo
- DRUG Azithromycin
- DRUG Cefixime
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
Why NCT01072136 stopped before completion
NCT01072136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01072136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01072136 about?
NCT01072136 is a clinical study titled "Empiric Therapy of Mucopurulent Cervicitis (MPC)". Mucopurulent cervicitis (MPC) is a syndrome with associated symptoms including mucopurulent discharge (mucus and pus) from the cervix and other signs of inflammation such as easily induced cervical bleeding. The purpose of this study is to evaluate the effectiveness of no treatment versus empiric tr...
What is the current status of trial NCT01072136?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2010-03. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01072136?
The interventions under investigation include: Placebo (OTHER), Azithromycin (DRUG), Cefixime (DRUG).
Who is sponsoring clinical trial NCT01072136?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01072136's enrollment target sits among peer trials
87 1742nd of 2000 higher than 256 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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