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Trial record 7 of 24 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate" | ( Map: United States )

Postmenopausal Pessary Users: Estrogen Versus Trimosan

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ClinicalTrials.gov Identifier: NCT03943823
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Gazala Siddiqui, The University of Texas Health Science Center, Houston

Brief 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.

Condition or disease Intervention/treatment Phase
Vaginosis Vaginosis, Bacterial Vaginal Discharge Drug: Estrogen vaginal cream Drug: Trimo-San vaginal gel Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Arm Intervention/treatment
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.
Other Names:
  • Estrace Cream
  • Premarin Cream

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




Primary Outcome Measures :
  1. Vaginal pH as measured by pH strips [ Time Frame: baseline ]
  2. Vaginal pH as measured by pH strips [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Vaginal Symptoms as assessed by a vaginitis questionnaire [ Time Frame: baseline ]
  2. Vaginal Symptoms as assessed by a vaginitis questionnaire [ Time Frame: 3 months ]
  3. 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.

  4. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Konny Fong 713-500-6574 Konny.ChanFong@uth.tmc.edu

Locations
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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   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Gazala Siddiqui, MD The University of Texas Health Science Center, Houston

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Responsible Party: Gazala Siddiqui, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03943823     History of Changes
Other Study ID Numbers: HSC-MS-15-0337
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gazala Siddiqui, The University of Texas Health Science Center, Houston:
Pessary
Vaginal pH
Additional relevant MeSH terms:
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Bacterial Infections
Estradiol
Vaginosis, Bacterial
Vaginal Diseases
Vaginal Discharge
Genital Diseases, Female
Vaginitis
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs