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Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

Primary Purpose

Vaginitis Atropic, Pelvic Organ Prolapse, Endometrial Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Conjugated Estrogen
Promestriene
Estriol
Vaginal Moisturizer - Cream
Sponsored by
Universidade Federal do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vaginitis Atropic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • post menopause women
  • normal oncotic cytology and mammogram
  • any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm

Exclusion Criteria:

  • vaginal bleeding
  • hormonal replacement on the past three months
  • renal or hepatic desease
  • porfiria
  • past venous thromboembolism; ulcerated prolapse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Conjugated Estrogen Group

    Promestriene Group

    Estriol Group

    Vaginal Moisturizer Cream

    Arm Description

    use of 1 gram per day

    use of 1 gram per day

    use of 1 gram per day

    use of 1 gram per day

    Outcomes

    Primary Outcome Measures

    Evaluate the histopathological effects on endometrium after each treatment
    Compare the histopathological results after treatment on each group and among each other
    Compare the endometrial thickness measured by ultrassound after each treatment
    Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other

    Secondary Outcome Measures

    Evaluate the changes of maturation index (Meisels Index) after each treatement
    Compare the changes on Meisels Index after each treatment and among each other
    Evaluate the changes on climacteric complaints after each treatment
    Compare the changes on systemic and genital complaints after each treatment, and among each other

    Full Information

    First Posted
    January 20, 2017
    Last Updated
    April 29, 2019
    Sponsor
    Universidade Federal do Paraná
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03032848
    Brief Title
    Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients
    Official Title
    Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 26, 2013 (Actual)
    Primary Completion Date
    December 20, 2016 (Actual)
    Study Completion Date
    December 26, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Paraná

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginitis Atropic, Pelvic Organ Prolapse, Endometrial Hyperplasia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conjugated Estrogen Group
    Arm Type
    Active Comparator
    Arm Description
    use of 1 gram per day
    Arm Title
    Promestriene Group
    Arm Type
    Active Comparator
    Arm Description
    use of 1 gram per day
    Arm Title
    Estriol Group
    Arm Type
    Active Comparator
    Arm Description
    use of 1 gram per day
    Arm Title
    Vaginal Moisturizer Cream
    Arm Type
    Placebo Comparator
    Arm Description
    use of 1 gram per day
    Intervention Type
    Drug
    Intervention Name(s)
    Conjugated Estrogen
    Other Intervention Name(s)
    Premarin
    Intervention Description
    use of 1 gram per day
    Intervention Type
    Drug
    Intervention Name(s)
    Promestriene
    Other Intervention Name(s)
    Colpotrofine
    Intervention Description
    use of 1 gram per day
    Intervention Type
    Drug
    Intervention Name(s)
    Estriol
    Other Intervention Name(s)
    Stelle
    Intervention Description
    use of 1 gram per day
    Intervention Type
    Drug
    Intervention Name(s)
    Vaginal Moisturizer - Cream
    Other Intervention Name(s)
    Vagidrat
    Intervention Description
    use of 1 gram per day
    Primary Outcome Measure Information:
    Title
    Evaluate the histopathological effects on endometrium after each treatment
    Description
    Compare the histopathological results after treatment on each group and among each other
    Time Frame
    48 days
    Title
    Compare the endometrial thickness measured by ultrassound after each treatment
    Description
    Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other
    Time Frame
    48 days
    Secondary Outcome Measure Information:
    Title
    Evaluate the changes of maturation index (Meisels Index) after each treatement
    Description
    Compare the changes on Meisels Index after each treatment and among each other
    Time Frame
    48 days
    Title
    Evaluate the changes on climacteric complaints after each treatment
    Description
    Compare the changes on systemic and genital complaints after each treatment, and among each other
    Time Frame
    48 days

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: post menopause women normal oncotic cytology and mammogram any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm Exclusion Criteria: vaginal bleeding hormonal replacement on the past three months renal or hepatic desease porfiria past venous thromboembolism; ulcerated prolapse

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    23985562
    Citation
    Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
    Results Reference
    result

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    Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

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