Trial Outcomes & Findings for Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment (NCT NCT03682601)
NCT ID: NCT03682601
Last Updated: 2022-07-27
Results Overview
Scale Title: Numerical Pain Scale to measure overall pain perceived from vulvar vestibule. Minimum value of scale: 0; Maximum value of scale: 10. Subjects were asked to rate from 0 to 10 pain perceived from their vulvar vestibule. The mean (standard error) for Numerical Pain Scale at each visit was calculated. A higher Numerical Rating Score means worse outcome and lower Numerical Rating Score means a better outcome. The following Numerical Rating Scale categories for Pain definition were utilized: 0=no pain, 1-3=mild pain, 4-6=moderate pain; 7-9=significant pain and 10=severe pain.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Numerical Rating Scale for pain was assessed at Visit 1 (initial visit); Visit 2 (at 2 weeks), and Visit 3 (at 4 weeks).
Results posted on
2022-07-27
Participant Flow
Participant milestones
| Measure |
Placebo
15 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
Placebo: Aquaphor/vehicle
|
5% Topical Sinecatechins Ointment
15 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily.
|
10% Topical Sinecatechins Ointment
15 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
7
|
13
|
|
Overall Study
COMPLETED
|
12
|
7
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
15 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
Placebo: Aquaphor/vehicle
|
5% Topical Sinecatechins Ointment
n=7 Participants
15 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily.
|
10% Topical Sinecatechins Ointment
n=13 Participants
15 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Numerical Rating Scale
|
8.6 units on a scale from 0 to 10
STANDARD_DEVIATION 0.9 • n=5 Participants
|
7.6 units on a scale from 0 to 10
STANDARD_DEVIATION 1.4 • n=7 Participants
|
8.3 units on a scale from 0 to 10
STANDARD_DEVIATION 0.8 • n=5 Participants
|
8.2 units on a scale from 0 to 10
STANDARD_DEVIATION 1.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: Numerical Rating Scale for pain was assessed at Visit 1 (initial visit); Visit 2 (at 2 weeks), and Visit 3 (at 4 weeks).Scale Title: Numerical Pain Scale to measure overall pain perceived from vulvar vestibule. Minimum value of scale: 0; Maximum value of scale: 10. Subjects were asked to rate from 0 to 10 pain perceived from their vulvar vestibule. The mean (standard error) for Numerical Pain Scale at each visit was calculated. A higher Numerical Rating Score means worse outcome and lower Numerical Rating Score means a better outcome. The following Numerical Rating Scale categories for Pain definition were utilized: 0=no pain, 1-3=mild pain, 4-6=moderate pain; 7-9=significant pain and 10=severe pain.
Outcome measures
| Measure |
Placebo
n=12 Participants
15 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
Placebo: Aquaphor/vehicle
|
5% Topical Sinecatechins Ointment
n=7 Participants
15 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily.
|
10% Topical Sinecatechins Ointment
n=13 Participants
15 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily.
|
|---|---|---|---|
|
Numerical Rating Scale for Pain
Visit 1 Numerical Rating Scale for pain
|
8.6 score on a scale from 0 to 10.
Standard Error 0.3
|
7.6 score on a scale from 0 to 10.
Standard Error 0.5
|
8.3 score on a scale from 0 to 10.
Standard Error 0.2
|
|
Numerical Rating Scale for Pain
Visit 2 Numerical Rating Scale for pain
|
6.4 score on a scale from 0 to 10.
Standard Error 0.6
|
4.0 score on a scale from 0 to 10.
Standard Error 0.8
|
6.3 score on a scale from 0 to 10.
Standard Error 0.6
|
|
Numerical Rating Scale for Pain
Visit 3 Numerical Rating Scale for pain
|
5.9 score on a scale from 0 to 10.
Standard Error 0.6
|
2.4 score on a scale from 0 to 10.
Standard Error 0.9
|
2.1 score on a scale from 0 to 10.
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Q-tip test score for pain was assessed at Visit 1 (initial visit); Visit 2 (at 2 weeks), and Visit 3 (at 4 weeks).Scale Title: Q-tip test of vulvar vestibular pain. Minimum value of scale: 0; Maximum value of scale: 10. Subjects were asked to rate from 0 to 10 pain perceived from their vulvar vestibule. The mean (standard error) for Q-tip test at each visit was calculated. A higher Q-tip score means worse outcome and lower Numerical Rating Score means a better outcome. The following Q-tip test categories for Pain definition were utilized: 0=no pain, 1-3=mild pain, 4-6=moderate pain; 7-9=significant pain and 10=severe pain.
Outcome measures
| Measure |
Placebo
n=12 Participants
15 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
Placebo: Aquaphor/vehicle
|
5% Topical Sinecatechins Ointment
n=7 Participants
15 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily.
|
10% Topical Sinecatechins Ointment
n=13 Participants
15 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily.
|
|---|---|---|---|
|
Q-tip Test Test for Pain on the Vulvar Vestibule
Visit 1 Q-tip test score
|
7.8 score on a scale from 0 to 10.
Standard Error 0.5
|
8.2 score on a scale from 0 to 10.
Standard Error 0.5
|
7.7 score on a scale from 0 to 10.
Standard Error 0.2
|
|
Q-tip Test Test for Pain on the Vulvar Vestibule
Visit 2 Q-tip test score
|
6.0 score on a scale from 0 to 10.
Standard Error 0.5
|
4.8 score on a scale from 0 to 10.
Standard Error 0.8
|
5.8 score on a scale from 0 to 10.
Standard Error 0.6
|
|
Q-tip Test Test for Pain on the Vulvar Vestibule
Visit 3 Q-tip test score
|
5.1 score on a scale from 0 to 10.
Standard Error 0.6
|
2.9 score on a scale from 0 to 10.
Standard Error 0.8
|
1.9 score on a scale from 0 to 10.
Standard Error 0.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5% Topical Sinecatechins Ointment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10% Topical Sinecatechins Ointment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
12 postmenopausal women will apply a 1/2 inch strand of Placebo ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
Placebo: Aquaphor/vehicle
|
5% Topical Sinecatechins Ointment
n=7 participants at risk
7 postmenopausal women will apply a 1/2 inch strand of 5% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
5% sinecatechins ointment: Topical 5% sinecatechins ointment will be applied once daily.
|
10% Topical Sinecatechins Ointment
n=13 participants at risk
13 postmenopausal women will apply a 1/2 inch strand of 10% sinecatechins topical ointment once daily to their vulvar vestibule for a total of 4 weeks.
They will come for three office visits with the gynecologist, who will exam their vulvar vestibule and perform a Qtip test. The Qtip test consists of applying pressure with a cotton tipped swab to the vulvar vestibule and asking the participant to rate the degree of pain that they experience on a scale from 0-10 ( 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-9=significant pain; 10=severe pain).
A swab will be taken of the lateral vaginal wall for to assess the degree of vaginal atrophy.
The participant will fill out questionnaire during office visits with the gynecologist. In addition, questionnaire will be filled out online on a HIPAA compliant web based survey at the end of weeks 1 and 3 and one week after stopping study ointment.
10% sinecatechins ointment: Topical 10% sinecatechins ointment will be applied three times per week up to once daily.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • 1 year
|
0.00%
0/7 • 1 year
|
30.8%
4/13 • Number of events 4 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place