Trial Outcomes & Findings for Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA (NCT NCT02784613)
NCT ID: NCT02784613
Last Updated: 2019-04-02
Results Overview
Change in score on the Vulvoscopic Genital Tissue Appearance (VGTA) scale from baseline to 20 weeks was measured using ten parameters: 1) loss of labia majora, 2) loss of labia minora, 3) decreased glans clitoris, 4) prominence of the urethral meatus, 5) stenosis of the introitus, 6) vestibular pallor, 7) vestibular erythema, 8) loss of vestibular moisture, 9) loss of vaginal rugae, and 10) loss of prominence of the anterior vaginal wall to determine health of the vulva, vestibule and vaginal region using vulvoscopic photographs. VGTA scoring ranges from 0 (normal) to 3 (most severe) for each parameter, for a total score ranging from 0 (normal) to 30 (most severe). Each region assessed is reflected as worse for a higher score and better for a lower score in the 0-3 range, and the same for the total score, with 0 being the best possible score and 30 the worse.
COMPLETED
PHASE4
10 participants
Baseline and 20 weeks
2019-04-02
Participant Flow
Participant milestones
| Measure |
Ospemifene Open Label
60 mg ospemifene daily for 20 weeks
Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
Baseline characteristics by cohort
| Measure |
Ospemifene Open Label
n=8 Participants
60 mg ospemifene daily for 20 weeks
Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 20 weeksChange in score on the Vulvoscopic Genital Tissue Appearance (VGTA) scale from baseline to 20 weeks was measured using ten parameters: 1) loss of labia majora, 2) loss of labia minora, 3) decreased glans clitoris, 4) prominence of the urethral meatus, 5) stenosis of the introitus, 6) vestibular pallor, 7) vestibular erythema, 8) loss of vestibular moisture, 9) loss of vaginal rugae, and 10) loss of prominence of the anterior vaginal wall to determine health of the vulva, vestibule and vaginal region using vulvoscopic photographs. VGTA scoring ranges from 0 (normal) to 3 (most severe) for each parameter, for a total score ranging from 0 (normal) to 30 (most severe). Each region assessed is reflected as worse for a higher score and better for a lower score in the 0-3 range, and the same for the total score, with 0 being the best possible score and 30 the worse.
Outcome measures
| Measure |
Open Label
n=8 Participants
60 mg ospemifene daily for 20 weeks
Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
|
|---|---|
|
Visible Changes to the Vulva, Vestibule and Vaginal Region on Photography
|
8 points improvement on VGTA scale
Interval 7.0 to 8.0
|
SECONDARY outcome
Timeframe: Baseline and 20 weeksPopulation: Completers
Changes in pain as noted on the pain scale (0-3) by q-tip testing of the vestibule by the clinician, with 0 representing no pain at the location and 3 being severe in each location, 1 o'clock, 3 o'clock, 5 o'clock, 6 o'clock, 7 o'clock, 9 o'clock and 11 o'clock circling the vestibule. The maximum total pain score range is 0 (no pain) to the worst score possible of 21 indicating severe pain at all locations.
Outcome measures
| Measure |
Open Label
n=8 Participants
60 mg ospemifene daily for 20 weeks
Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
|
|---|---|
|
Changes in Pain Scale
|
10 points improvement
Interval 9.5 to 13.0
|
SECONDARY outcome
Timeframe: Baseline and 20 weeksPopulation: completers
For each sexual encounter, patients were required to record a ''yes" or "no" response to the following question: Did you experience pain during intercourse? The percentage of sexual encounters in which the woman answered "yes" to this question at baseline (first month of the study) and at week 20 (last month of the study) was compared. The worst score possible was experiencing pain during 100% of sexual encounters and the best possible score was experiencing pain during 0% of sexual encounters at any given assessment period.
Outcome measures
| Measure |
Open Label
n=8 Participants
60 mg ospemifene daily for 20 weeks
Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
|
|---|---|
|
Percentage of Sexual Encounters in Which Pain Was Experienced
Baseline value
|
80 percentage of sexual encounters
Interval 20.0 to 100.0
|
|
Percentage of Sexual Encounters in Which Pain Was Experienced
Week 20 value
|
0 percentage of sexual encounters
Interval 0.0 to 0.0
|
Adverse Events
Open Label
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label
n=8 participants at risk
60 mg ospemifene daily for 20 weeks
Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
|
|---|---|
|
Renal and urinary disorders
microscopic hematuria
|
12.5%
1/8 • Number of events 1 • 6 months per participant
clinical trials dot gov definitions used
|
|
Respiratory, thoracic and mediastinal disorders
influenza
|
12.5%
1/8 • Number of events 1 • 6 months per participant
clinical trials dot gov definitions used
|
|
Infections and infestations
sinus infection
|
12.5%
1/8 • Number of events 1 • 6 months per participant
clinical trials dot gov definitions used
|
|
Gastrointestinal disorders
diarrhea
|
12.5%
1/8 • Number of events 1 • 6 months per participant
clinical trials dot gov definitions used
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
12.5%
1/8 • Number of events 1 • 6 months per participant
clinical trials dot gov definitions used
|
|
Respiratory, thoracic and mediastinal disorders
acute coryza
|
12.5%
1/8 • Number of events 1 • 6 months per participant
clinical trials dot gov definitions used
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place