Postmenopausal Pessary Users: Estrogen Versus Trimosan
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03943823|
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vaginosis Vaginosis, Bacterial Vaginal Discharge||Drug: Estrogen vaginal cream Drug: Trimo-San vaginal gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Postmenopausal Pessary Users: Estrogen Versus Trimosan|
|Estimated Study Start Date :||May 7, 2019|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||May 1, 2022|
|Active Comparator: Estrogen vaginal cream||
Drug: Estrogen vaginal 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.
|Active Comparator: Trimo-San vaginal gel||
Drug: Trimo-San vaginal gel
Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
Other Name: Trimo-San
- Vaginal pH as measured by pH strips [ Time Frame: baseline ]
- Vaginal pH as measured by pH strips [ Time Frame: 3 months ]
- Vaginal Symptoms as assessed by a vaginitis questionnaire [ Time Frame: baseline ]
- Vaginal Symptoms as assessed by a vaginitis questionnaire [ Time Frame: 3 months ]
- Number of participants with vaginosis infection [ Time Frame: baseline ]Vaginosis infection will be diagnosed either by gram staining or an Affirm bacterial vaginosis (BV) test, which probes for DNA of microorganisms that cause BV.
- Number of participants with vaginosis infection [ Time Frame: 3 months ]Vaginosis infection will be diagnosed either by gram staining or by an Affirm bacterial vaginosis (BV) test, which probes for DNA of microorganisms that cause BV.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943823
|Contact: Konny Fong||713-500-6574||Konny.ChanFong@uth.tmc.edu|
|United States, Texas|
|The University of Texas Health Science Center at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Konny Fong 713-500-6574 Konny.ChanFong@uth.tmc.edu|
|Principal Investigator:||Gazala Siddiqui, MD||The University of Texas Health Science Center, Houston|