Trial · NCT02099006
Novel Topical Therapies for the Treatment of Genital Pain
NCT02099006, Phase 2, Phase 3, Completed, University of Rochester; results first posted 2016-07-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Novel Topical Therapies for the Treatment of Genital Pain. Trials, record NCT02099006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02099006
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Novel Topical Therapies for the Treatment of Genital Pain
- NCT number
- NCT02099006
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Female Genital Diseases
- Interventions
- Amitriptyline, Baclofen, Ketoprofen, Ketamine, Loperamide, Gabapentin, placebo
- First posted
- 2014-03-28
- Last updated
- 2016-07-15
- Results first posted
- 2016-07-15
- Limitations and caveats
- The small number of patients recruited left this study underpowered to uncover significant effects with the medications studied.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in Daily Genital Pain. | 13 weeks | Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of "0" was defined as no pain and a score of "10" was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated. |
| Secondary | Reduction in Tampon Test Pain | 13 weeks | Reduction in the pain, as measured on a 10 point Likert scale, associated with the insertion and removal of a tampon. This is a validated surrogate for pain associated with intercourse. Subjects were asked to insert and remove a tampon each week and report the degree of pain associated with this. A score of "0" was defined as no pain, and a score of "10" was defined as worst imaginable pain. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reduction in Daily Genital Pain. | 13 weeks | For each placebo entry the data is limited to include only those participates who also received the named intervention. | units on a scale | MEAN |
| SECONDARY | Reduction in Tampon Test Pain | 13 weeks | For each placebo entry the data is limited to include only those participates who also received the named intervention. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction in Daily Genital Pain. | Medications | Loperamide | 2.4 | Standard Deviation 1.94 | units on a scale |
| Reduction in Daily Genital Pain. | Placebo | Loperamide | 2.92 | Standard Deviation 2.3 | units on a scale |
| Reduction in Daily Genital Pain. | Medications | Ketamine | 3.42 | Standard Deviation 2.45 | units on a scale |
| Reduction in Daily Genital Pain. | Placebo | Ketamine | 2.77 | Standard Deviation 2.46 | units on a scale |
| Reduction in Daily Genital Pain. | Medications | Gabapentin | 3.70 | Standard Deviation 2.92 | units on a scale |
| Reduction in Daily Genital Pain. | Placebo | Gabapentin | 3.41 | Standard Deviation 2.55 | units on a scale |
| Reduction in Daily Genital Pain. | Medications | amtriptyline/baclofen | 3.87 | Standard Deviation 2.74 | units on a scale |
| Reduction in Daily Genital Pain. | Placebo | amtriptyline/baclofen | 3.61 | Standard Deviation 2.68 | units on a scale |
| Reduction in Daily Genital Pain. | Medications | ketoprofen | 5.05 | Standard Deviation 3.34 | units on a scale |
| Reduction in Daily Genital Pain. | Placebo | ketoprofen | 5.05 | Standard Deviation 3.45 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Study Participants | 9 | |
| Overall Study | Received Placebo | All Study Participants | 9 | |
| Overall Study | Received Amitriptyline/ Baclofen | All Study Participants | 7 | |
| Overall Study | Received Ketoprofen | All Study Participants | 3 | |
| Overall Study | Received Loperamide | All Study Participants | 7 | |
| Overall Study | Received Ketamine | All Study Participants | 6 | |
| Overall Study | Received Gabapentin | All Study Participants | 8 | |
| Overall Study | COMPLETED | All Study Participants | 8 | |
| Overall Study | NOT COMPLETED | All Study Participants | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medications | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Medications | 0 | 9 |
| Total, other adverse events | Placebo | 0 | 9 |
| Total, serious adverse events | Medications | 0 | 9 |
| Total, serious adverse events | Placebo | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Medications vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02099006
GET https://conductscience.org/api/trials/v1/NCT02099006/registered