Pelvic Organ Prolapse (POP)Phase 3VEPONCT07030426
Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
A Phase 3 study testing Vaginal Estrogen - Twice Weekly and Vaginal Estrogen - Daily in people with Pelvic Organ Prolapse (POP), run by Sarah Wozney at 2 sites in Canada.
Trial summary
This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) repair surgery. This is a pilot trial that will examine the feasibility of the study, focussing on recruitment rates. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP)
- What is being tested?
- Vaginal Estrogen - Twice Weekly and Vaginal Estrogen - Daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2026to 30 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all the following inclusion criteria to be eligible for enrollment into the study:
- Participant who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- The participant has given written consent after the study has been explained according to local regulatory requirements and before any study specific procedures.
- Age ≥18 years at the time of consent.
- Undergoing an apical suspension (vaginal or abdominal, mesh or native tissue) for pelvic organ prolapse at one of the participating centers.
- Primary or recurrent prolapse surgery without a history of mesh surgery.
- Willing to complete surveys related to demographics, pelvic health and function, and sexual health and function.
- Plans to reside in the study area for at least 2 years after their surgery.
Who cannot join
- Any individual meeting any of the following criteria is not eligible for participation in this study:
- Participant undergoing anterior and/or posterior repair only (no apical prolapse repair).
- Participant undergoing obliterative procedures.
- Participant with a history of mesh surgery for prolapse.
- Participant undergoing uterine sparing surgery.
- Participant with a contraindication to vaginal estrogen use, including but not limited to the following list, at the discretion of the study investigator:
Show all 18Show fewer
- Patients who are hypersensitive to the drug or to any ingredient in the formulation or component of the container.
- Liver dysfunction or disease as long as liver function tests have failed to return to normal.
- Known or suspected estrogen-dependent malignant neoplasia (e.g. endometrial cancer).
- Endometrial hyperplasia.
- Known, suspected, or past history of breast cancer.
- Undiagnosed abnormal genital bleeding.
- Known or suspected pregnancy
- Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease).
- Partial or complete loss of vision due to ophthalmic vascular disease.
- Known thrombophilic disorders (e.g., protein C, protein S OR antithrombin deficiency); prothrombin mutation or anticardiolipin antibodies).
- Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of care, such as behavioral or cognitive impairment or neuropsychiatric illness.
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L2V7
Jessica Pudwell, MPH, MSc, 613-549-6666 ext. 3937, jessica.pudwell@queensu.ca
Kira King, 613-549-6666 ext. 2740, kira.king@kingstonhsc.ca
- Not yet recruiting
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3X5
Nermina Azar
Chelsea Harris
About this study
Official title: A Multi-center, Randomized, Open-label, Parallel-group, Feasibility-controlled Trial of Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) repair surgery. This is a pilot trial that will examine the feasibility of the study, focussing on recruitment rates. Participants will be randomized to one of three groups; (1) no vaginal estrogen for 6 weeks, (2) vaginal estrogen twice weekly for 6 weeks, or (3) vaginal estrogen daily for 6 weeks. Participants will be seen at 6 weeks post surgery, 6 months post surgery, 1 year and 2 years post surgery. Additional outcomes will include patient satisfaction, Genitourinary Syndrome of Menopause (GSM) symptoms, post-operative complications, adherence and safety.
Read the detailed description
Multi-center, randomized, open-label, parallel-group, feasibility-controlled trial
The intervention is the use of vaginal estrogen for 6 weeks after pelvic organ prolapse surgery. Participants will be randomized into 3 groups:
- No vaginal estrogen
- Vaginal estrogen 2 times per week
- Vaginal estrogen daily
Participants may be enrolled after diagnosis of pelvic organ prolapse and decision to proceed with surgery. Participants will be seen for a randomization visit within 6 weeks of their scheduled surgery. The intervention lasts from the day of surgery until 6 weeks after surgery. Participants will be seen for a post-operative follow-up visit at 6 weeks, and study follow-up visits at 6 months, 1 year and 2 years.
Sample Size: N=60 in each group, for a total of N=180 participants. For this pilot trial, we will recruit approximately 15% of the sample size required for the full-scale trial. Data from this pilot trial will be used to adjust the event rate in the sample size calculation for the full trial, if needed. Our sample size accounts for a non-compliance rate of 5% and a loss to follow-up rate of 5%.
After enrollment, participants will complete a baseline questionnaire that collects information on demographics and health history. This may be completed online via an email link sent through REDCap, in person on a hard copy questionnaire, or the questions can be administered verbally by study staff.
After enrollment, a study investigator or delegate will complete a case report for that collects additional information on the participant's pregnancy and pelvic health history.
At each study visit, a study investigator or delegate will complete a case report form that captures any changes in the participant's health history since the previous visit.
At all post-surgical visits, a study investigator or delegate will collect information in these same case report forms on complications and treatment failure. The questions in these case report forms will be administered verbally, with verification through chart review as appropriate or as needed.
At each study visit a Pelvic Organ Prolapse Quantification (POP-Q) and Visual Analog Scale (VAS) on GSM symptoms assessment will be completed by a study investigator or medical learner under direct supervision of a study investigator. As well, height, weight and blood pressure will be measured. If any of these are collected/done for clinical reasons at the same visit, the clinically collected data will be used for study purposes. The measurements and assessments will not be repeated for study purposes.
At each study visit the Prolapse Quality of Life Questionnaire (P-QOL) and incontinence questionnaires including the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), the Incontinence Impact Questionnaire Short Form (IIQ-7), and the Urogenital Distress Inventory Short Form (UDI-6) will be administered. These may be completed online via an email link sent through REDCap, in person on a hard copy questionnaire, or the questions can be administered verbally by study staff.
At the 6 week and 6 month post-surgical visit the Surgical Satisfaction Questionnaire (SSQ-8) will be administered. These may be completed online via an email link sent through REDCap, in person on a hard copy questionnaire, or the questions can be administered verbally by study staff.
At the 6 week post-surgical visit adherence to the study intervention will be assessed through collection of study product diaries and by querying participants on vaginal estrogen usage in the intervention period.
- Conditions
- Pelvic Organ Prolapse (POP)
- Being tested
- Vaginal Estrogen - Twice Weekly, Vaginal Estrogen - Daily
- Keywords
- pelvic organ prolapse, vaginal estrogen, pelvic organ prolapse surgery, pelvic organ prolapse repair
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Estrogen - Twice WeeklyDrug
Also called Conjugated Estrogens CSD, 0.625 mg/g, Vaginal Cream
Twice weekly for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime .
Vaginal Estrogen - DailyDrug
Also called Conjugated Estrogens CSD, 0.625 mg/g, Vaginal Cream
Daily for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime.
| Study group | Role | What they receive |
|---|---|---|
| No Vaginal Estrogen Group | No intervention | No vaginal estrogen |
| Twice Weekly Vaginal Estrogen Group | Active comparator | Twice Weekly Vaginal Estrogen Receives: Drug: Vaginal Estrogen - Twice Weekly |
| Daily Vaginal Estrogen Group | Active comparator | Daily Vaginal Estrogen Receives: Drug: Vaginal Estrogen - Daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
For the primary feasibility outcome, the trial will be considered feasible if at least 75% of the target sample can be recruited in 12 months.
Measured: 12 months
Secondary outcomes (17)
Loss to Follow Up Rate - 6 months
Loss to follow up rates at each of the study end points measured as n/N (%).
Measured: 6 Months post surgery
Loss to Follow Up Rate - 1 year
Loss to follow up rates at each of the study end points measured as n/N (%).
Measured: 1 year post surgery
Loss to Follow Up Rate - 2 years
Loss to follow up rates at each of the study end points measured as n/N (%).
Measured: 2 years post surgery
Patient Satisfaction - 6 weeks
Patient satisfaction will be assessed using the Surgical Satisfaction Questionnaire (SSQ-8). This questionnaire measures satisfaction with the surgical procedure on a scale from 8 (most satisfied) to 40 (least satisfied).
Measured: 6 weeks post surgery
Patient Satisfaction - 6 months
Patient satisfaction will be assessed using the Surgical Satisfaction Questionnaire (SSQ-8). This questionnaire measures satisfaction with the surgical procedure on a scale from 8 (most satisfied) to 40 (least satisfied).
Measured: 6 months post surgery
GSM Symptoms - 6 weeks
GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms.
Measured: 6 weeks post surgery
GSM Symptoms - 6 months
GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms.
Measured: 6 weeks post surgery
GSM Symptoms - 1 year
GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms.
Measured: 1 year post surgery
GSM Symptoms - 2 years
GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms.
Measured: 2 years post surgery
Prolapse Quality of Life - 6 weeks
The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life.
Measured: 6 weeks post surgery
Prolapse Quality of Life - 6 months
The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life.
Measured: 6 months post surgery
Prolapse Quality of Life - 1 year
The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life.
Measured: 1 year post surgery
Prolapse Quality of Life - 2 years
The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life.
Measured: 2 years post surgery
Complications - 6 weeks
A composite measure of the incidence of mesh erosion, urinary tract and/or surgical site infections and treatment failure.
Measured: 6 weeks post surgery
Complications - 6 months
A composite measure of the incidence of mesh erosion, urinary tract and/or surgical site infections and treatment failure.
Measured: 6 months post surgery
Treatment Failure - 1 year
A composite measure of the incidence of mesh erosion and treatment failure.
Measured: 1 year post surgery
Treatment Failure - 2 years
A composite measure of the incidence of mesh erosion and treatment failure.
Measured: 2 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jan 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Wozney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Wozney, Queen's University
- Investigators
- Sarah Wozney, MD, MScHQ, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030426
- Sponsor's protocol ID
- Ref: No 70577
- Acronym
- VEPO
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified study data in the REDCap database will be retained on the Queen's CAC system for 15 years after study results are published. After the 15 year data retention period the data and data dictionary from the study REDCap database will be made available in a public data archive such as the Queen's University Library Research Data Archive in the Scholars Portal Dataverse.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Parallel-group, Feasibility-controlled Trial of Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
- ClinicalTrials.gov ID
- NCT07030426
- Acronym / sponsor ID
- VEPO / Ref: No 70577
- Conditions
- Pelvic Organ Prolapse (POP)
- Keywords
- pelvic organ prolapse, vaginal estrogen, pelvic organ prolapse surgery, pelvic organ prolapse repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sarah WozneyUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) repair surgery. This is a pilot trial that will examine the feasibility of the study, focussing on recruitment rates. Participants will be randomized to one of three groups; (1) no vaginal estrogen for 6 weeks, (2) vaginal estrogen twice weekly for 6 weeks, or (3) vaginal estrogen daily for 6 weeks. Participants will be seen at 6 weeks post surgery, 6 months post surgery, 1 year and 2 years post surgery. Additional outcomes will include patient satisfaction, Genitourinary Syndrome of Menopause (GSM) symptoms, post-operative complications, adherence and safety.
Detailed description
Multi-center, randomized, open-label, parallel-group, feasibility-controlled trial
The intervention is the use of vaginal estrogen for 6 weeks after pelvic organ prolapse surgery. Participants will be randomized into 3 groups:
- No vaginal estrogen
- Vaginal estrogen 2 times per week
- Vaginal estrogen daily
Participants may be enrolled after diagnosis of pelvic organ prolapse and decision to proceed with surgery. Participants will be seen for a randomization visit within 6 weeks of their scheduled surgery. The intervention lasts from the day of surgery until 6 weeks after surgery. Participants will be seen for a post-operative follow-up visit at 6 weeks, and study follow-up visits at 6 months, 1 year and 2 years.
Sample Size: N=60 in each group, for a total of N=180 participants. For this pilot trial, we will recruit approximately 15% of the sample size required for the full-scale trial. Data from this pilot trial will be used to adjust the event rate in the sample size calculation for the full trial, if needed. Our sample size accounts for a non-compliance rate of 5% and a loss to follow-up rate of 5%.
After enrollment, participants will complete a baseline questionnaire that collects information on demographics and health history. This may be completed online via an email link sent through REDCap, in person on a hard copy questionnaire, or the questions can be administered verbally by study staff.
After enrollment, a study investigator or delegate will complete a case report for that collects additional information on the participant's pregnancy and pelvic health history.
At each study visit, a study investigator or delegate will complete a case report form that captures any changes in the participant's health history since the previous visit.
At all post-surgical visits, a study investigator or delegate will collect information in these same case report forms on complications and treatment failure. The questions in these case report forms will be administered verbally, with verification through chart review as appropriate or as needed.
At each study visit a Pelvic Organ Prolapse Quantification (POP-Q) and Visual Analog Scale (VAS) on GSM symptoms assessment will be completed by a study investigator or medical learner under direct supervision of a study investigator. As well, height, weight and blood pressure will be measured. If any of these are collected/done for clinical reasons at the same visit, the clinically collected data will be used for study purposes. The measurements and assessments will not be repeated for study purposes.
At each study visit the Prolapse Quality of Life Questionnaire (P-QOL) and incontinence questionnaires including the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), the Incontinence Impact Questionnaire Short Form (IIQ-7), and the Urogenital Distress Inventory Short Form (UDI-6) will be administered. These may be completed online via an email link sent through REDCap, in person on a hard copy questionnaire, or the questions can be administered verbally by study staff.
At the 6 week and 6 month post-surgical visit the Surgical Satisfaction Questionnaire (SSQ-8) will be administered. These may be completed online via an email link sent through REDCap, in person on a hard copy questionnaire, or the questions can be administered verbally by study staff.
At the 6 week post-surgical visit adherence to the study intervention will be assessed through collection of study product diaries and by querying participants on vaginal estrogen usage in the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Vaginal Estrogen Group | No intervention | –No vaginal estrogen |
| Twice Weekly Vaginal Estrogen Group | Active comparator | Drug: Vaginal Estrogen - Twice WeeklyTwice Weekly Vaginal Estrogen |
| Daily Vaginal Estrogen Group | Active comparator | Drug: Vaginal Estrogen - DailyDaily Vaginal Estrogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must meet all the following inclusion criteria to be eligible for enrollment into the study:
- Participant who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- The participant has given written consent after the study has been explained according to local regulatory requirements and before any study specific procedures.
- Age ≥18 years at the time of consent.
- Undergoing an apical suspension (vaginal or abdominal, mesh or native tissue) for pelvic organ prolapse at one of the participating centers.
Key exclusion criteria (18 listed)
- Any individual meeting any of the following criteria is not eligible for participation in this study:
- Participant undergoing anterior and/or posterior repair only (no apical prolapse repair).
- Participant undergoing obliterative procedures.
- Participant with a history of mesh surgery for prolapse.
- Participant undergoing uterine sparing surgery.
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 |
|---|---|---|
| Vaginal Estrogen - Twice WeeklyAlso: Conjugated Estrogens CSD, 0.625 mg/g, Vaginal CreamTwice weekly for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime . | Drug | Twice Weekly Vaginal Estrogen Group |
| Vaginal Estrogen - DailyAlso: Conjugated Estrogens CSD, 0.625 mg/g, Vaginal CreamDaily for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime. | Drug | Daily Vaginal Estrogen Group |
Primary outcome
Recruitment Rate
Time frame: 12 months
For the primary feasibility outcome, the trial will be considered feasible if at least 75% of the target sample can be recruited in 12 months.
17 secondary outcomes
Loss to Follow Up Rate - 6 months
Time frame: 6 Months post surgery
Loss to Follow Up Rate - 1 year
Time frame: 1 year post surgery
Loss to Follow Up Rate - 2 years
Time frame: 2 years post surgery
Patient Satisfaction - 6 weeks
Time frame: 6 weeks post surgery
Patient Satisfaction - 6 months
Time frame: 6 months post surgery
GSM Symptoms - 6 weeks
Time frame: 6 weeks post surgery
GSM Symptoms - 6 months
Time frame: 6 weeks post surgery
GSM Symptoms - 1 year
Time frame: 1 year post surgery
GSM Symptoms - 2 years
Time frame: 2 years post surgery
Prolapse Quality of Life - 6 weeks
Time frame: 6 weeks post surgery
Prolapse Quality of Life - 6 months
Time frame: 6 months post surgery
Prolapse Quality of Life - 1 year
Time frame: 1 year post surgery
Prolapse Quality of Life - 2 years
Time frame: 2 years post surgery
Complications - 6 weeks
Time frame: 6 weeks post surgery
Complications - 6 months
Time frame: 6 months post surgery
Treatment Failure - 1 year
Time frame: 1 year post surgery
Treatment Failure - 2 years
Time frame: 2 years post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified study data in the REDCap database will be retained on the Queen's CAC system for 15 years after study results are published. After the 15 year data retention period the data and data dictionary from the study REDCap database will be made available in a public data archive such as the Queen's University Library Research Data Archive in the Scholars Portal Dataverse.
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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.
Sarah Wozney, MD, MScHQ principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaginal Estrogen - Twice Weekly and Vaginal Estrogen - Daily in people with Pelvic Organ Prolapse (POP), run by Sarah Wozney at 2 sites in Canada.
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 8 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessca Pudwell, MPH, MSc (613-549-6666 ext. 3937, jessica.pudwell@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 12 months). 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 20 Aug 2026.