VaginosisPhase 4NCT03943823
Postmenopausal Pessary Users: Estrogen Versus Trimosan
A Phase 4 study testing Estrogen vaginal cream and Trimo-San vaginal gel in people with Vaginosis and Vaginosis, Bacterial, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Vaginosis, Vaginosis, Bacterial, Vaginal Discharge
- What is being tested?
- Estrogen vaginal cream and Trimo-San vaginal gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2019to 8 Apr 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy
- Is a new pessary user, or has not had a pessary for a year
Who cannot join
- Pregnancy
- Persistent Bacterial Vaginosis infection in the first two clinic encounters
- Currently on hormone replacement therapy
- Previously on hormone replacement therapy in the past 6 months
- Currently on antibiotics
- Patients with existing vaginal erosions/ulcerations
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.
- Conditions
- Vaginosis, Vaginosis, Bacterial, Vaginal Discharge
- Being tested
- Estrogen vaginal cream, Trimo-San vaginal gel
- Keywords
- Pessary, Vaginal pH
- Medical subject headings
- Vaginal Diseases, Vaginosis, Bacterial, Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estrogen vaginal creamDrug
Also called Estrace Cream, Premarin Cream
Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
Trimo-San vaginal gelDrug
Also called Trimo-San
Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Estrogen vaginal cream | Active comparator | Not described Receives: Drug: Estrogen vaginal cream |
| Trimo-San vaginal gel | Active comparator | Not described Receives: Drug: Trimo-San vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal pH as Measured by pH Strips
pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
Measured: baseline
Vaginal pH as Measured by pH Strips
pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
Measured: 3 months
Secondary outcomes (2)
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Measured: baseline
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start7 May 2019
- Primary completion8 Mar 2021
- Study completion8 Apr 2021
Why it stopped: Difficulties in recruiting and retaining patients due to the COVID pandemic; lack of availability of study drug trimosan; lack of study personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VaginosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gazala Siddiqui, The University of Texas Health Science Center, Houston
- Investigators
- Gazala Siddiqui, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943823
- Sponsor's protocol ID
- HSC-MS-15-0337
- Status last verified
- Mar 2023
- First submitted
- 7 May 2019
- Last updated
- 8 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmenopausal Pessary Users: Estrogen Versus Trimosan
- ClinicalTrials.gov ID
- NCT03943823
- Acronym / sponsor ID
- HSC-MS-15-0337
- Conditions
- Vaginosis, Vaginosis, Bacterial, Vaginal Discharge
- Keywords
- Pessary, Vaginal pH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting and retaining patients due to the COVID pandemic; lack of availability of study drug trimosan; lack of study personnel
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estrogen vaginal cream | Active comparator | Drug: Estrogen vaginal cream |
| Trimo-San vaginal gel | Active comparator | Drug: Trimo-San vaginal gel |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy
- Is a new pessary user, or has not had a pessary for a year
Key exclusion criteria (6 listed)
- Pregnancy
- Persistent Bacterial Vaginosis infection in the first two clinic encounters
- Currently on hormone replacement therapy
- Previously on hormone replacement therapy in the past 6 months
- Currently on antibiotics
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 |
|---|---|---|
| Estrogen vaginal creamAlso: Estrace Cream, Premarin CreamEither Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly. | Drug | Estrogen vaginal cream |
| Trimo-San vaginal gelAlso: Trimo-SanHalf applicator for three times a week for 1st week, then half applicator for 2 times a week. | Drug | Trimo-San vaginal gel |
Primary outcome
Vaginal pH as Measured by pH Strips
Time frame: baseline
pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
Vaginal pH as Measured by pH Strips
Time frame: 3 months
pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
2 secondary outcomes
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Time frame: baseline
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gazala Siddiqui, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estrogen vaginal cream and Trimo-San vaginal gel in people with Vaginosis and Vaginosis, Bacterial, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal pH as Measured by pH Strips (time frame: baseline). The study lists 2 primary outcomes in all. 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 8 Mar 2023.