Pelvic Floor DisordersPhase 4NCT01886794
Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
A Phase 4 study testing Postmenopausal, topical vaginal estrogen cream in people with Pelvic Floor Disorders, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Postmenopausal, topical vaginal estrogen cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2013to 11 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 to 70 years of age
- Stage II or greater pelvic organ prolapse (POP)
- Individuals electing surgery to treat their POP
- Willing and able to comply with study procedures
- Willing and able to provide written informed consent
Who cannot join
- Contraindication for estrogen cream
- Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation
- History of connective tissue disease
- Previous hysterectomy or pelvic organ prolapse surgery
- Known allergic reaction to any agent required by the protocol
- Use of hormone therapy in postmenopausal women in the last 90 days
- Pregnant or lactating females
- History of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.
Read the detailed description
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments. We will perform in vivo evaluations with colposcopy and OCT to determine epithelial thickness and overall mucosal health prior to surgery. At the time of surgery, we will obtain tissue for histologic and imaging analysis.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Postmenopausal, topical vaginal estrogen cream, Placebo Comparator: Postmenopausal, topical placebo cream
- Keywords
- pelvic floor dysfunction, pelvic organ prolapse, vaginal estrogen effects
- Medical subject headings
- Pelvic Floor Disorders, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postmenopausal, topical vaginal estrogen creamDrug
Also called Estrace vaginal 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.
Placebo Comparator: Postmenopausal, topical placebo creamDrug
Also called Placebo vaginal cream
Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal, topical vaginal cream | Experimental | 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. Receives: Drug: Postmenopausal, topical vaginal estrogen cream |
| Pre-menopausal, no topical vaginal cream | No intervention | 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 | Placebo comparator | 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. Receives: Drug: Placebo Comparator: Postmenopausal, topical placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Epithelial Thickness
Measure of vaginal epithelial thickness obtained by optical coherence tomography
Measured: 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).
Secondary outcomes (1)
Histologic Assessment of Excised Tissue
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)
Measured: 1 month after visit 1 (3-17days after visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study start6 Jun 2013
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Why it stopped: Collaborator moved and not able to recreate full study team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Vincent, MD, Principal investigator, UTMB Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886794
- Sponsor's protocol ID
- 13-114
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2013
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT01886794
- Acronym / sponsor ID
- 13-114
- Conditions
- Pelvic Floor Disorders
- Keywords
- pelvic floor dysfunction, pelvic organ prolapse, vaginal estrogen effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Collaborator moved and not able to recreate full study team
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 6 Jun 2013 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.
Detailed description
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments. We will perform in vivo evaluations with colposcopy and OCT to determine epithelial thickness and overall mucosal health prior to surgery. At the time of surgery, we will obtain tissue for histologic and imaging analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal, topical vaginal cream | Experimental | Drug: Postmenopausal, topical vaginal estrogen creamPostmenopausal 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. |
| Pre-menopausal, no topical vaginal cream | No intervention | –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 | Placebo comparator | Drug: Placebo Comparator: Postmenopausal, topical placebo creamPostmenopausal 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 to 70 years of age
- Stage II or greater pelvic organ prolapse (POP)
- Individuals electing surgery to treat their POP
- Willing and able to comply with study procedures
- Willing and able to provide written informed consent
Key exclusion criteria (8 listed)
- Contraindication for estrogen cream
- Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation
- History of connective tissue disease
- Previous hysterectomy or pelvic organ prolapse surgery
- Known allergic reaction to any agent required by the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postmenopausal, topical vaginal estrogen creamAlso: Estrace vaginal creamTopical 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. | Drug | Postmenopausal, topical vaginal cream |
| Placebo Comparator: Postmenopausal, topical placebo creamAlso: Placebo vaginal creamPostmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery. | Drug | Postmenopausal, topical placebo cream |
Primary outcome
Vaginal Epithelial Thickness
Time frame: 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).
Measure of vaginal epithelial thickness obtained by optical coherence tomography
1 secondary outcome
Histologic Assessment of Excised Tissue
Time frame: 1 month after visit 1 (3-17days after visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to the clinic where recruitment will be performedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Vincent, MD principal investigator
UTMB Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Postmenopausal, topical vaginal estrogen cream in people with Pelvic Floor Disorders, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Epithelial Thickness (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.