A Phase 4 interventional study of Conjugated Estrogens Cream in Female Urogenital Diseases, Vaginal Atrophy and Postmenopausal Atrophic Vaginitis, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Basic science
Among 23 studies in Atrophic Vaginitis with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Atrophic Vaginitis · United States.
Among the 23 studies in Atrophic Vaginitis with a site in United States, this one is the 19th largest by enrollment, is the only one that started in 2019, is one of 5 in phase 4, and was the 18th registered.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's enrollment of 25 is below the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →2 of the 23 studies in Atrophic Vaginitis with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 4 Atrophic Vaginitis studies recruiting now, 3 (75%) set no upper age limit and 1 (25%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 55 Years and older · female · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2019.
Median enrollment 69 across the 23 interventional studies. Of the 21 that completed or were terminated, 12 (57%) have results posted.
15 of 23 have an industry lead sponsor. The 10 most frequent:
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
University of Alabama at Birmingham has 1 study filed under Atrophic Vaginitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Atrophic Vaginitis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of vaginal estrogen use. The investigators plan to characterize the composition and dynamics of the microbiomes of the vagina, bladder, and rectum for quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) before and after eight weeks of local vaginal estrogen therapy. Although the vagina, bladder, and gut microbiomes have been increasingly independently studied, less is known about the interactions of the bacterial communities among the three environments as well as the dynamic relationship with menopausal status and vaginal estrogen therapy and the investigators seek to elucidate these relationships further.
This is an open-label pilot study of vaginal estrogen therapy in postmenopausal participants with vulvovaginal atrophy. The investigators seek to evaluate the effects of vaginal estrogen therapy on the vaginal, urinary, and rectal bacterial communities (microbiomes) and assess the (i) quantitative change in relative abundance of Lactobacillus among the community composition of bacteria in the vagina, and (ii) to evaluate the vaginal maturation index (VMI), vaginal pH, and vaginal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF (IL - Interleukin, TNF - tumor necrosis factor, MCP - monocyte chemoattractant protein, GM - granulocyte macrophage, CSF - colony stimulating factor) and correlate any notable changes with changes noted in the vaginal microbiome, and (iii and iv) observe for quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) among the bladder and rectal microbiomes. These changes will also be compared to the results yielded from the vaginal microbiome analysis. Additionally the investigators will assess for quantitative changes in the bladder and rectal inflammatory biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF) and correlate these findings with any notable changes in the bladder and rectal microbiomes. Furthermore, changes in these biomarkers will be compared with the data (inflammatory and microbial) yielded from vaginal sampling. Bio-specimens and patient questionnaires will be assessed at baseline and again after eight weeks of vaginal estrogen therapy.
20 participants will receive the intervention (vaginal estrogen therapy) for 8 weeks. 5 participants who meet the same inclusion/exclusion criteria will not receive the intervention and will be sampled at the same time points. The additional 5 participants are intended to serve as a control cohort to demonstrate stability of the microbiome over the study period. The 5 participants may be compared to the 20 participants receiving therapy but that is not part of the primary or secondary outcomes.
The investigators believe that examining the dynamic relationships of the genitourinary-rectal region is innovative and vital to validating the investigator's understanding and assumptions of the pathophysiology and treatment approaches of this disorder.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's enrollment of 25 is below the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Compared within Atrophic Vaginitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Female Urogenital Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
Drug: Conjugated Estrogens Cream
No intervention will be given.
0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
Also known as: Premarin Vaginal Cream
Quantitative Change in Relative Abundance of Lactobacillus Among the Community Composition of Bacteria in the Vagina
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.
Time frame: Baseline, 8 weeks
Change in Vaginal Maturation Index (VMI)
The 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.
Time frame: Baseline, 8 weeks
Change in Vaginal pH
Change in the vaginal pH from baseline to 8 weeks
Time frame: Baseline, 8 weeks
Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF
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
Time frame: Baseline, 8 weeks
Quantitative and Qualitative Changes in the Distribution of Operational Taxonomic Units (OTUs) in the Bladder Microbiome.
Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.
Time frame: Baseline, 8 weeks
Quantitative and Qualitative Changes in the Distribution of Operational Taxonomic Units (OTUs) in the Rectal Microbiome.
Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.
Time frame: Baseline, 8 weeks
Bladder Inflammatory Biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF)
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
Time frame: Baseline, 8 weeks
Rectal Inflammatory Biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF)
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
Time frame: Baseline, 8 weeks
| Milestone | Conjugated Estrogens Cream | Control Cohort |
|---|---|---|
| Started | 20 | 5 |
| Completed | 16 | 5 |
| Not completed | 4 | 0 |
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.
| Relative abundance | Conjugated Estrogens Cream | Control Cohort |
|---|---|---|
| Baseline | 0.07 (0.02 to 0.14) | 0.09 (0.03 to 0.45) |
| 8 weeks | 0.12 (0.06 to 0.96) | 0.04 (0.04 to 0.2) |
The 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.
| Change in vaginal maturation index value | Conjugated Estrogens Cream | Control Cohort |
|---|---|---|
| Baseline | 35 (10 to 47.5) | 42.5 (17.5 to 50) |
| 8 weeks | 60 (50 to 65) | 47.5 (45 to 52.5) |
Change in the vaginal pH from baseline to 8 weeks
| Vaginal pH | Conjugated Estrogens Cream | Control Cohort |
|---|---|---|
| Baseline | 7.25 (6.5 to 7.5) | 7 (5.5 to 8.0) |
| 8 weeks | 5 (4.5 to 5.5) | 7 (5.5 to 7.5) |
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
| pg/mg | Conjugated Estrogens Cream | Control Cohort |
|---|---|---|
| IL-1b BASELINE | 44.4 (5.9 to 84.9) | 132.9 (28.8 to 236.9) |
| IL-1b 8 WEEKS | 10.8 (4.0 to 26.0) | 373.6 (10.2 to 737.1) |
| IL-4 BASELINE | 10.0 (5.3 to 23.1) | 18.1 (2.3 to 33.8) |
| IL-4 8 WEEKS | 2.1 (1.3 to 4.2) | 11.1 (5.0 to 17.2) |
| IL-8 BASELINE | 3158.2 (1956.2 to 8087.5) | 3724.3 (2254.4 to 5194.2) |
| IL-8 8 WEEKS | 757.5 (260.0 to 1980.3) | 7941.0 (2247.8 to 13643.2) |
| IL-10 BASELINE | 22.5 (14.9 to 38.2) | 12.7 (1.7 to 22.1) |
| IL-10 8 WEEKS | 640.7 (NA to NA) | 7.0 (5.1 to 14.3) |
| TNF-a BASELINE | 9.3 (8.9 to 56.9) | 11.6 (6.1 to 39.7) |
| TNF-a 8 WEEKS | 7.1 (6.5 to 10.1) | 12.0 (7.2 to 30.5) |
| MCP-1 BASELINE | 102.5 (22.1 to 232.1) | 29.1 (24.4 to 186.7) |
| MCP-1 8 WEEKS | 6.7 (3.3 to 31.3) | 59.0 (19.8 to 79.1) |
Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.
No measurements were reported for this outcome.
Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conjugated Estrogens Cream | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Control Cohort | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Conjugated Estrogens Cream | Control Cohort | Total |
|---|---|---|---|
| Median | 65.5 (57 to 71) | 71 (61 to 77) | 66 (57 to 73) |
| Sex: Female, Male(Participants) | Conjugated Estrogens Cream | Control Cohort | Total |
|---|---|---|---|
| Female | 20 | 5 | 25 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Conjugated Estrogens Cream | Control Cohort | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 2 | 7 |
| White | 14 | 3 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Conjugated Estrogens Cream | Control Cohort | Total |
|---|---|---|---|
| United States | 20 | 5 | 25 |
| Body Mass Index(kg/m^2) | Conjugated Estrogens Cream | Control Cohort | Total |
|---|---|---|---|
| Median | 27.3 (23.8 to 30.9) | 30.9 (21 to 31.5) | 27.3 (22.4 to 31.7) |
| Parity(births) | Conjugated Estrogens Cream | Control Cohort | Total |
|---|---|---|---|
| Median | 2 (1.5 to 2) | 2 (1 to 2) | 2 (1 to 2) |
| Spontaneous Vaginal Delivery(deliveries) | Conjugated Estrogens Cream | Control Cohort | Total |
|---|---|---|---|
| Median | 2 (0.5 to 2) | 1 (1 to 2) | 2 (0.5 to 2) |
| Hysterectomy(Participants) | Conjugated Estrogens Cream | Control Cohort | Total |
|---|---|---|---|
| Count of participants | 10 | 2 | 12 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2019 to primary completion in Jan 2021, 17 months.
Results were first posted in May 2024, 3 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Conjugated estrogens
University of Alabama at Birmingham →