Your session is about to expire
← Back to Search
Estrogen
Vaginal Estradiol Treatments for Recurrent Urinary Tract Infections
Phase 4
Recruiting
Led By Candace Parker-Autry, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Not currently taking daily prophylactic antibiotics
Women age 20-80 who are post-menopausal or have undergone surgical menopause. Post-menopausal defined as amenorrhea for ≥ 1 year, or surgical menopause through bilateral oophorectomy, or menopausal symptoms for ≥ 1 year in women with prior hysterectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3 and month 6
Awards & highlights
Study Summary
This trial tested the preference of post-menopausal women with rUTI for a vaginal estradiol tablet over a vaginal estrogen cream.
Who is the study for?
This trial is for post-menopausal women aged 20-80, who have had recurrent UTIs and are willing to use vaginal estrogen for prevention. They shouldn't be on daily antibiotics, hormone replacement therapy, or have certain medical conditions like uncontrolled diabetes or active cancers sensitive to estrogen.Check my eligibility
What is being tested?
The study compares the preference of women with recurrent urinary tract infections (rUTI) between two forms of vaginally applied estrogen: a cream and a tablet. It aims to determine which form increases compliance in using the treatment.See study design
What are the potential side effects?
Potential side effects may include local irritation, hormonal changes such as breast tenderness or bleeding, headaches, nausea, and possible increased risk of blood clots similar to other estrogen treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not on daily antibiotics to prevent infections.
Select...
I am a woman aged 20-80 and am post-menopausal or have had surgical menopause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3 and month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3 and month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient preference rate for vaginal estradiol cream versus tablet
Secondary outcome measures
Change in overall satisfaction, convenience, side effects, and effectiveness of vaginal estradiol cream vs tablet using Treatment Satisfaction Questionnaire for Medication (TSQM)
Change in vaginal and urinary microbiome Lactobacillus amount with the use of vaginal estradiol tablet versus cream
Changes in adherence scores
Trial Design
2Treatment groups
Active Control
Group I: cream used first and then switch to tabletsActive Control2 Interventions
participants will start with 3 months of cream and then switch to tablets
Group II: tablets used first and switch to creamActive Control2 Interventions
participants will start with 3 months of tablets and switch to cream
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,706 Total Patients Enrolled
Candace Parker-Autry, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
208 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot keep a vaginal tablet in place because of a severe prolapse or previous colpocleisis surgery.I can't visit the clinic for follow-ups or to give samples due to transportation problems.I have had 3 or more UTIs in the past year or 2 in the last 6 months, with at least one confirmed by culture.I am not on daily antibiotics to prevent infections.I have not used vaginal estrogen in the last month.I am currently on hormone replacement therapy.I have issues controlling my bladder, poorly managed diabetes, or a history of certain cancers.I am willing to use vaginal estrogen to prevent UTIs.I have a history of bladder issues, kidney stones, urinary tract problems, or kidney surgery.I had surgery related to my urinary system in the last 3 months.I have health issues that prevent me from using vaginal estrogen.I am a woman aged 20-80 and am post-menopausal or have had surgical menopause.I have had an organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: cream used first and then switch to tablets
- Group 2: tablets used first and switch to cream
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is the process of transitioning from topical application to oral ingestion for patients?
"Data from Power suggests the safety of this cream-to-tablet treatment regimen to be a 3, as it has been approved by regulators and is in its fourth phase of clinical trials."
Answered by AI
May I be considered for participation in this experiment?
"To qualify for this clinical trial, potential subjects must possess recurrent urinary tract infections and fall between the age range of 20 to 80 years old. 24 individuals will be accepted into the study."
Answered by AI
Is this research endeavor enrolling individuals over the age of 45?
"To be eligible for this study, applicants must between 20 and 80 years of age. Moreover, 353 trials are available to people below the legal age of consent while 1475 studies target senior citizens."
Answered by AI
Are there any opportunities to participate in this scientific experiment at the moment?
"As per the information located on clinicaltrials.gov, this trial is not in need of participants at this moment in time. This study was initially posted on February 1st 2023 and has been updated recently with no changes to its recruitment status. However, there are still 1759 other trials that have active recruitment needs right now."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger