Trial Outcomes & Findings for Novel Topical Therapies for the Treatment of Genital Pain (NCT NCT02099006)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

9 participants

Primary outcome timeframe

13 weeks

Results posted on

2016-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants Each study subject was sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study. Amitriptyline 2%/ Baclofen 2%: Topical application of the drug at a 2% concentration in combination with 2% Baclofen Ketoprofen: To be applied topically at a 10% concentration Ketamine: To be applied topically at a 10% concentration Loperamide: To be applied topically at a 5% concentration Gabapentin: To be applied topically at a 6% concentration
Overall Study STARTED	9
Overall Study Received Placebo	9
Overall Study Received Amitriptyline/ Baclofen	7
Overall Study Received Ketoprofen	3
Overall Study Received Loperamide	7
Overall Study Received Ketamine	6
Overall Study Received Gabapentin	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel Topical Therapies for the Treatment of Genital Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=9 Participants Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study. Amitriptyline/ Baclofen: Topical application of the drug at a 2% concentration in combination with 2% Baclofen Ketoprofen: To be applied topically at a 10% concentration Ketamine: To be applied topically at a 10% concentration Loperamide: To be applied topically at a 5% concentration Gabapentin: To be applied topically at a 6% concentration
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

Population: For each placebo entry the data is limited to include only those participates who also received the named intervention.

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.

Outcome measures

Outcome measures
Measure	Medications n=9 Participants Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study. Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline Ketoprofen: To be applied topically at a 10% concentration Ketamine: To be applied topically at a 10% concentration Loperamide: To be applied topically at a 5% concentration Gabapentin: To be applied topically at a 6% concentration	Placebo n=9 Participants The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order. placebo: Compounding base to be used alone as a placebo
Reduction in Daily Genital Pain. Loperamide	2.4 units on a scale Standard Deviation 1.94	2.92 units on a scale Standard Deviation 2.3
Reduction in Daily Genital Pain. Ketamine	3.42 units on a scale Standard Deviation 2.45	2.77 units on a scale Standard Deviation 2.46
Reduction in Daily Genital Pain. Gabapentin	3.70 units on a scale Standard Deviation 2.92	3.41 units on a scale Standard Deviation 2.55
Reduction in Daily Genital Pain. amtriptyline/baclofen	3.87 units on a scale Standard Deviation 2.74	3.61 units on a scale Standard Deviation 2.68
Reduction in Daily Genital Pain. ketoprofen	5.05 units on a scale Standard Deviation 3.34	5.05 units on a scale Standard Deviation 3.45

SECONDARY outcome

Timeframe: 13 weeks

Population: For each placebo entry the data is limited to include only those participates who also received the named intervention.

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.

Outcome measures

Outcome measures
Measure	Medications n=9 Participants Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study. Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline Ketoprofen: To be applied topically at a 10% concentration Ketamine: To be applied topically at a 10% concentration Loperamide: To be applied topically at a 5% concentration Gabapentin: To be applied topically at a 6% concentration	Placebo n=9 Participants The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order. placebo: Compounding base to be used alone as a placebo
Reduction in Tampon Test Pain loperamide	4.71 units on a scale Standard Deviation 2.75	5.29 units on a scale Standard Deviation 3.21
Reduction in Tampon Test Pain ketamine	5.92 units on a scale Standard Deviation 3.56	5.92 units on a scale Standard Deviation 3.00
Reduction in Tampon Test Pain gabapentin	5.125 units on a scale Standard Deviation 3.57	4.875 units on a scale Standard Deviation 3.19
Reduction in Tampon Test Pain ketoprofen	6.17 units on a scale Standard Deviation 3.18	6.0 units on a scale Standard Deviation 3.46
Reduction in Tampon Test Pain amitriptyline/baclofen	5.43 units on a scale Standard Deviation 2.75	5.36 units on a scale Standard Deviation 3.12

Adverse Events

Medications

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adrienne Bonham MD

University of Rochester

Phone: (585) 273-3314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place