Phase 4
N=20
Effect of Nicotine on Chronic Pelvic Pain
Pelvic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00440505 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Pain Score — 7.1; 6.4; 6.9 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Nicotine (5 mg) (Drug); Nicotine (10 mg) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score |
7.1; 6.4; 6.9 | — |
| SECONDARY Patient Self-assessment of Psychological Distress |
40.2; 36.7; 37.5 | — |
| SECONDARY Number of Participants Who Reported an Increase in Daily Pain Medication Regime |
2; 3; 2 | — |
| SECONDARY Nausea |
2.3; 2.3; 2.3 | — |
Summary
The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.
Eligibility Criteria
Inclusion Criteria
- Chronic pelvic pain
- Aged 18-60 years
- Female
Exclusion Criteria
- Uncontrolled hypertension
- Cardiovascular disease
- Current analgesic abuse
- Pregnancy
- Current usage of nicotine patch or gum
- Allergy to adhesive tape
Data sourced from ClinicalTrials.gov (NCT00440505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.