Trial Outcomes & Findings for Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse (NCT NCT01886794)
NCT ID: NCT01886794
Last Updated: 2025-10-29
Results Overview
Measure of vaginal epithelial thickness obtained by optical coherence tomography
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
7 participants
Primary outcome timeframe
Change in thickness visit 1 to visit 2 for the postmenopausal group (approximately 1 month apart), and change in thickness from follicular to luteal phase for premenopausal group (approximately 1 month apart).
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Postmenopausal, Topical Vaginal Cream
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream.
Postmenopausal, topical vaginal estrogen cream: Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.
|
Pre-menopausal, no Topical Vaginal Cream
Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints.
|
Postmenopausal, Topical Placebo Cream
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo.
Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
2
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
Baseline characteristics by cohort
| Measure |
Postmenopausal, Topical Vaginal Cream
n=2 Participants
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream.
Postmenopausal, topical vaginal estrogen cream: Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.
|
Pre-menopausal, no Topical Vaginal Cream
n=3 Participants
Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints.
|
Postmenopausal, Topical Placebo Cream
n=2 Participants
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo.
Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
56 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change in thickness visit 1 to visit 2 for the postmenopausal group (approximately 1 month apart), and change in thickness from follicular to luteal phase for premenopausal group (approximately 1 month apart).Population: All participants who enrolled were analyzed for this outcome measure.
Measure of vaginal epithelial thickness obtained by optical coherence tomography
Outcome measures
| Measure |
Postmenopausal, Topical Vaginal Cream
n=2 Participants
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream.
Postmenopausal, topical vaginal estrogen cream: Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.
|
Pre-menopausal, no Topical Vaginal Cream
n=3 Participants
Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints.
|
Postmenopausal, Topical Placebo Cream
n=2 Participants
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo.
Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
|
|---|---|---|---|
|
Vaginal Epithelial Thickness
|
80 micrometers
Standard Deviation 23
|
25.5 micrometers
Standard Deviation 2.5
|
-11 micrometers
Standard Deviation 5
|
SECONDARY outcome
Timeframe: 1 month after visit 1 (3-17days after visit 2)Population: Histology was performed for the postmenopausal, topical vaginal cream, and the pre-menopausal, no topical vaginal cream group. There was no histology available from the 2 postmenopausal subjects randomly assigned to the placebo cream group.
Evaluated tissue samples obtained during surgery to examine collagen. Collagen score (Masson trichrome): 3=abundant collagen (dark blue stain), 2=collagen present (light blue stain), 1=scant collagen (minimal blue stain) Higher scores indicate more collagen, or better outcome. (note that study vaginal drug was stopped at visit 2 for postmenopausal subjects except in one subject who used active topical vaginal cream but stopped after 2 weeks due to AE. Her OCT score was obtained after 2 weeks of active cream, however the histology was obtained 2 weeks after discontinuation of study drug because Visit 2 was scheduled at the time of the AE and at the time of stopping the active cream. The OCT and histology results are not concordant due to being taken at different timepoints (visit 2 on active cream vs surgery 16 days later off cream)
Outcome measures
| Measure |
Postmenopausal, Topical Vaginal Cream
n=2 Participants
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream.
Postmenopausal, topical vaginal estrogen cream: Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.
|
Pre-menopausal, no Topical Vaginal Cream
n=3 Participants
Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints.
|
Postmenopausal, Topical Placebo Cream
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo.
Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
|
|---|---|---|---|
|
Histologic Assessment of Excised Tissue
|
2.0 score on a scale
Standard Deviation 1.0
|
2.3 score on a scale
Standard Deviation 0.5
|
—
|
Adverse Events
Postmenopausal, Topical Vaginal Cream
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pre-menopausal, no Topical Vaginal Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Postmenopausal, Topical Placebo Cream
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Postmenopausal, Topical Vaginal Cream
n=2 participants at risk
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream.
Postmenopausal, topical vaginal estrogen cream: Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.
|
Pre-menopausal, no Topical Vaginal Cream
n=3 participants at risk
Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints.
|
Postmenopausal, Topical Placebo Cream
n=2 participants at risk
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo.
Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Vulvovaginal discomfort/itching
|
100.0%
2/2 • Number of events 2 • AE's were collected during the time the subjects were enrolled in the study, which was 4-6 weeks.
|
0.00%
0/3 • AE's were collected during the time the subjects were enrolled in the study, which was 4-6 weeks.
|
50.0%
1/2 • Number of events 1 • AE's were collected during the time the subjects were enrolled in the study, which was 4-6 weeks.
|
Additional Information
Kathleen L. Vincent, M.D.
University of Texas Medical Branch
Phone: 409-772-2610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place