BridgeMD
Compares treatment options for Cystitis, Recurrent
Official title Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis
ClinicalTrials.gov ID: NCT07186465
What this study is testing
What is Nitrofurantoin?
Nitrofurantoin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for cystitis, recurrent.
Also referred to as Nitrofurantoin macrocrystals/monohydrate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This open-label, parallel-group randomized controlled trial compares two prophylaxis strategies for recurrent urinary tract infection (rUTI) in postmenopausal women: (1) nightly oral nitrofurantoin 100 mg for 6 months versus (2) a vaginal tablet containing Lactobacillus with ultra-low-dose estriol (Gynoflor: nightly for 14 days, then twice weekly to month 6). Participants (≥40 years) are randomized 1:1 in computer-generated blocks and followed for 6 months.
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- Female, postmenopausal, age ≥40 years
- Clinical history of recurrent urinary tract infection (rUTI) as assessed by the investigator
- Able and willing to take assigned prophylaxis for 6 months
- Able to attend baseline and Month 6 study visits and provide urine samples
- Able to provide written informed consent
You likely can't join if
- Current symptomatic UTI at enrollment (may be treated and reconsidered after resolution)
- Known hypersensitivity or contraindication to nitrofurantoin or to the Lactobacillus/estriol vaginal tablet (Gynoflor) or their excipients...
- Planned urologic surgery or procedure expected during the 6-month study period
- Recent bacterial vaginosis (e.g., within the past month) or active vulvovaginal skin disorders precluding vaginal product use
- History of hormone-dependent malignancy (e.g., breast, uterine, or cervical cancer) or unexplained abnormal vaginal bleeding
- Significant liver disease (e.g., active hepatitis) or other conditions judged by the investigator to make participation unsafe
See the full eligibility criteria
- Female, postmenopausal, age ≥40 years
- Clinical history of recurrent urinary tract infection (rUTI) as assessed by the investigator
- Able and willing to take assigned prophylaxis for 6 months
- Able to attend baseline and Month 6 study visits and provide urine samples
- Able to provide written informed consent
- Willing and able to complete twice-weekly phone/LINE follow-ups
- Current symptomatic UTI at enrollment (may be treated and reconsidered after resolution)
- Known hypersensitivity or contraindication to nitrofurantoin or to the Lactobacillus/estriol vaginal tablet (Gynoflor) or their excipients; significant renal impairment or other label-based contraindications to...
- Planned urologic surgery or procedure expected during the 6-month study period
- Recent bacterial vaginosis (e.g., within the past month) or active vulvovaginal skin disorders precluding vaginal product use
- History of hormone-dependent malignancy (e.g., breast, uterine, or cervical cancer) or unexplained abnormal vaginal bleeding
- Significant liver disease (e.g., active hepatitis) or other conditions judged by the investigator to make participation unsafe
- Participation in another treatment trial that could interfere with outcomes
- Withdrawal of consent or severe adverse event requiring discontinuation
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Phayatai Ratchathewi, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Phayatai Ratchathewi, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.