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RECRUITING NA

Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause

NCT05672901 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is: \- Will StrataMGT be non-inferior regarding patient quality of life compared to standard of care? Participants will use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. After the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.

Interventions

  • DEVICE StrataMGT
  • DRUG Estrace 0.01% Vaginal Cream

Study Locations (3)

California

  • Orange Coast Women's Medical Group — Laguna Hills

Florida

  • Abba Medical Group — Miami

Georgia

  • One Health Research Clinic — Johns Creek

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-04-04
Est. Completion 2026-09
Phase NA

Sponsor

Stratpharma

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05672901

The ClinicalTrials.gov registry entry for NCT05672901 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stratpharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Genitourinary Syndrome of Menopause appearing as the primary indexed condition, and to 2 interventions — of which StrataMGT is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05672901 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05672901 about?

NCT05672901 is a clinical study titled "Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause". The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is: \- Will StrataMGT be non-inferior regarding patient quality of life compared to stan...

What is the current status of trial NCT05672901?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-04-04. Estimated completion is 2026-09.

What conditions does trial NCT05672901 study?

This clinical trial studies the following conditions: Genitourinary Syndrome of Menopause. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05672901?

The interventions under investigation include: StrataMGT (DEVICE), Estrace 0.01% Vaginal Cream (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05672901?

This trial is sponsored by Stratpharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05672901 being conducted?

This trial has 3 study locations across California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial