Trial Outcomes & Findings for Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy (NCT NCT03996603)
NCT ID: NCT03996603
Last Updated: 2024-05-07
Results Overview
The relative abundance of the Lactobacillus genus, as measured by 16S ribosomal RNA (rRNA) gene sequencing, is the proportion of Lactobacillus genus among the total vaginal microbiome. After analysis of the gene sequencing, the total yield of bacteria at the genus level equals 1. The quantitative change in relative abundance of Lactobacillus among the community composition of bacteria in the vagina will be assessed from baseline to 8 weeks. The investigators hypothesize that a pre-specified statistically significant quantitative increase in the relative abundance of Lactobacillus will be seen among the participants that receive treatment.
COMPLETED
PHASE4
25 participants
Baseline, 8 weeks
2024-05-07
Participant Flow
Participant milestones
| Measure |
Conjugated Estrogens Cream
0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
|
Control Cohort
No intervention will be given.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
5
|
|
Overall Study
COMPLETED
|
16
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
Baseline characteristics by cohort
| Measure |
Conjugated Estrogens Cream
n=20 Participants
0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
|
Control Cohort
n=5 Participants
No intervention will be given.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
n=5 Participants
|
71 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Body Mass Index
|
27.3 kg/m^2
n=5 Participants
|
30.9 kg/m^2
n=7 Participants
|
27.3 kg/m^2
n=5 Participants
|
|
Parity
|
2 births
n=5 Participants
|
2 births
n=7 Participants
|
2 births
n=5 Participants
|
|
Spontaneous Vaginal Delivery
|
2 deliveries
n=5 Participants
|
1 deliveries
n=7 Participants
|
2 deliveries
n=5 Participants
|
|
Hysterectomy
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Prior Prolapse Surgery
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Prior SUI Surgery
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Recurrent UTIs
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diabetes Mellitus
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Currently on OAB/UUI Medication(s)
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Currently Sexually Active
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Vaginal pH
|
6.8 pH
n=5 Participants
|
7 pH
n=7 Participants
|
7 pH
n=5 Participants
|
|
Vaginal Maturation Index
|
37.5 units on a scale
n=5 Participants
|
40 units on a scale
n=7 Participants
|
40 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksThe relative abundance of the Lactobacillus genus, as measured by 16S ribosomal RNA (rRNA) gene sequencing, is the proportion of Lactobacillus genus among the total vaginal microbiome. After analysis of the gene sequencing, the total yield of bacteria at the genus level equals 1. The quantitative change in relative abundance of Lactobacillus among the community composition of bacteria in the vagina will be assessed from baseline to 8 weeks. The investigators hypothesize that a pre-specified statistically significant quantitative increase in the relative abundance of Lactobacillus will be seen among the participants that receive treatment.
Outcome measures
| Measure |
Conjugated Estrogens Cream
n=20 Participants
0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
|
Control Cohort
n=5 Participants
No intervention will be given.
|
|---|---|---|
|
Quantitative Change in Relative Abundance of Lactobacillus Among the Community Composition of Bacteria in the Vagina
Baseline
|
0.07 Relative abundance
Interval 0.02 to 0.14
|
0.09 Relative abundance
Interval 0.03 to 0.45
|
|
Quantitative Change in Relative Abundance of Lactobacillus Among the Community Composition of Bacteria in the Vagina
8 weeks
|
0.12 Relative abundance
Interval 0.06 to 0.96
|
0.04 Relative abundance
Interval 0.04 to 0.2
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksThe maturation value (MV) is calculated with the following formula: MV = % surface cells + (0.5 × % intermediate cells). The outcome data is reported as the delta change from baseline to 8 weeks. The data for the primary outcome has been entered using the "measure type - NUMBER" because the outcome is a delta or change in the vaginal maturation index.
Outcome measures
| Measure |
Conjugated Estrogens Cream
n=20 Participants
0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
|
Control Cohort
n=5 Participants
No intervention will be given.
|
|---|---|---|
|
Change in Vaginal Maturation Index (VMI)
Baseline
|
35 Change in vaginal maturation index value
Interval 10.0 to 47.5
|
42.5 Change in vaginal maturation index value
Interval 17.5 to 50.0
|
|
Change in Vaginal Maturation Index (VMI)
8 weeks
|
60 Change in vaginal maturation index value
Interval 50.0 to 65.0
|
47.5 Change in vaginal maturation index value
Interval 45.0 to 52.5
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksChange in the vaginal pH from baseline to 8 weeks
Outcome measures
| Measure |
Conjugated Estrogens Cream
n=20 Participants
0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
|
Control Cohort
n=5 Participants
No intervention will be given.
|
|---|---|---|
|
Change in Vaginal pH
Baseline
|
7.25 Vaginal pH
Interval 6.5 to 7.5
|
7 Vaginal pH
Interval 5.5 to 8.0
|
|
Change in Vaginal pH
8 weeks
|
5 Vaginal pH
Interval 4.5 to 5.5
|
7 Vaginal pH
Interval 5.5 to 7.5
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Only one specimen resulted in a value for IL-10 post-treatment.
Change in the vaginal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks
Outcome measures
| Measure |
Conjugated Estrogens Cream
n=20 Participants
0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
Conjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
|
Control Cohort
n=5 Participants
No intervention will be given.
|
|---|---|---|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
IL-1b BASELINE
|
44.4 pg/mg
Interval 5.9 to 84.9
|
132.9 pg/mg
Interval 28.8 to 236.9
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
IL-1b 8 WEEKS
|
10.8 pg/mg
Interval 4.0 to 26.0
|
373.6 pg/mg
Interval 10.2 to 737.1
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
IL-4 BASELINE
|
10.0 pg/mg
Interval 5.3 to 23.1
|
18.1 pg/mg
Interval 2.3 to 33.8
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
IL-4 8 WEEKS
|
2.1 pg/mg
Interval 1.3 to 4.2
|
11.1 pg/mg
Interval 5.0 to 17.2
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
IL-8 BASELINE
|
3158.2 pg/mg
Interval 1956.2 to 8087.5
|
3724.3 pg/mg
Interval 2254.4 to 5194.2
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
IL-8 8 WEEKS
|
757.5 pg/mg
Interval 260.0 to 1980.3
|
7941.0 pg/mg
Interval 2247.8 to 13643.2
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
IL-10 BASELINE
|
22.5 pg/mg
Interval 14.9 to 38.2
|
12.7 pg/mg
Interval 1.7 to 22.1
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
IL-10 8 WEEKS
|
640.7 pg/mg
Only one specimen resulted a value for IL-10 post treatment.
|
7.0 pg/mg
Interval 5.1 to 14.3
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
TNF-a BASELINE
|
9.3 pg/mg
Interval 8.9 to 56.9
|
11.6 pg/mg
Interval 6.1 to 39.7
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
TNF-a 8 WEEKS
|
7.1 pg/mg
Interval 6.5 to 10.1
|
12.0 pg/mg
Interval 7.2 to 30.5
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
MCP-1 BASELINE
|
102.5 pg/mg
Interval 22.1 to 232.1
|
29.1 pg/mg
Interval 24.4 to 186.7
|
|
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
MCP-1 8 WEEKS
|
6.7 pg/mg
Interval 3.3 to 31.3
|
59.0 pg/mg
Interval 19.8 to 79.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeksPopulation: There was only one participant and there was no range.
Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeksPopulation: This data was never collected.
Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeksPopulation: This data was never collected.
Change in the concentration of bladder inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 8 weeksPopulation: This data was never collected.
Change in the concentration of rectal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks
Outcome measures
Outcome data not reported
Adverse Events
Conjugated Estrogens Cream
Control Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kyle Norris, MD Principal Investigator
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place