Vaginal Estrogen for Pelvic Organ Prolapse

(VEPO Trial)

Not yet recruiting at 1 trial location

Overseen By Kira King

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Queen's University

Disqualifiers: Mesh surgery, Breast cancer, Thromboembolic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how vaginal estrogen might aid recovery after pelvic organ prolapse surgery. It tests whether using estrogen in the first six weeks post-surgery improves outcomes like patient satisfaction and reduces menopause symptoms affecting the urinary and genital areas. Participants will join one of three groups: no estrogen, twice-weekly estrogen, or daily estrogen for six weeks. Ideal participants are those undergoing a specific type of prolapse surgery (apical suspension) without a history of mesh surgery and are willing to engage in follow-up for two years. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment nearing widespread availability.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that vaginal estrogen is usually well-tolerated. In studies, most people using it did not experience serious side effects. Some users reported mild issues like irritation or discharge, but these were not severe. Importantly, many women have safely used vaginal estrogen to manage menopause symptoms, supporting its safety. While every treatment carries risks, current evidence suggests that vaginal estrogen is safe for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using vaginal estrogen for pelvic organ prolapse because it offers a targeted approach to addressing symptoms. Unlike other treatments that may involve surgery or systemic hormone therapy, vaginal estrogen is applied directly to the affected area, potentially reducing side effects. The trial is exploring different dosing strategies, with both twice-weekly and daily applications, to determine the most effective regimen. This targeted delivery method may improve local tissue health and support, offering a non-surgical option that could be more convenient and comfortable for many patients.

What evidence suggests that this trial's treatments could be effective for pelvic organ prolapse?

Research has shown that vaginal estrogen can significantly benefit women with pelvic organ prolapse (POP). One study found that 94% of women experienced substantial improvement in prolapse symptoms after surgery when using vaginal estrogen. This trial will compare different regimens of vaginal estrogen, including daily and twice-weekly applications, to a group not using it. The treatment also appears to reduce the risk of surgical failure compared to a placebo cream. Additionally, vaginal estrogen may enhance sexual function and improve the quality of life for postmenopausal women with POP. Overall, these findings suggest that vaginal estrogen could be a valuable option for managing symptoms and aiding recovery after POP surgery. ^{1 4 5 6 7}

Who Is on the Research Team?

Sarah Wozney, MD, MScHQ

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for individuals over 18 years old who have undergone pelvic organ prolapse repair surgery and can follow the study's protocol. They should plan to stay in the study area for two years post-surgery, be willing to complete various health surveys, and not have a history of mesh surgery or conditions that could affect participation.

Inclusion Criteria

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

Plans to reside in the study area for at least 2 years after their surgery

Exclusion Criteria

I am undergoing a procedure to block a body passage.

I am having surgery that will not remove my uterus.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vaginal estrogen or no treatment for 6 weeks following pelvic organ prolapse surgery

6 weeks

1 visit (in-person) at 6 weeks post-surgery

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction at multiple intervals post-treatment

2 years

Visits at 6 months, 1 year, and 2 years post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Vaginal Estrogen

Trial Overview The trial examines how vaginal estrogen affects recovery after pelvic organ prolapse surgery. Participants are divided into three groups: no treatment, twice-weekly estrogen application, or daily application for six weeks. Follow-ups occur at intervals up to two years post-surgery.

How Is the Trial Designed?

Group I: No Vaginal Estrogen Group Active Control 1 Intervention

No vaginal estrogen

Group II: Twice Weekly Vaginal Estrogen Group Active Control 1 Intervention

Twice Weekly Vaginal Estrogen

Group III: Daily Vaginal Estrogen Group Active Control 1 Intervention

Daily Vaginal Estrogen

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38710269/

Three-year outcomes of a randomized clinical trial ... - PubMed The primary report's outcome was time to failure by 12 months postoperatively, defined by a composite outcome of objective prolapse of the ...

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.18260

The Role of Vaginal Oestrogen Therapy in Postmenopausal ... Background. Pelvic organ prolapse (POP) affects up to 50% of postmenopausal women, negatively impacting sexual function and quality of life.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937824005684

Three-year outcomes of a randomized clinical trial ... Nonetheless, overall, 94% of participants reported that their prolapse symptoms were much or very much improved at 36 months after surgery. Despite previous ...

4. ajog.org ajog.org/article/S0002-9378(24)00568-4/abstract

Three-year outcomes of a randomized clinical trial ... This study aimed to compare the efficacy of perioperative vaginal estrogen vs placebo cream in reducing composite surgical treatment failure 36 months after ...

5. bmj.com bmj.com/content/389/bmj-2025-084418

Effects of intravaginal conjugated oestrogen on pessary ... Objective To examine the effect of vaginal oestrogen cream on pessary continuation rates in pelvic organ prolapse. Design Multicentre, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07030426

Vaginal Estrogen for Improvement of Outcomes Following ... This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37581673/

Perioperative Vaginal Estrogen as Adjunct to Native Tissue ... Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair.