Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

Sponsor
Universidade Federal do ParanĂ¡ (Other)
Overall Status
Completed
CT.gov ID
NCT03032848
Collaborator
(none)
69
4
37

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients
Actual Study Start Date :
Nov 26, 2013
Actual Primary Completion Date :
Dec 20, 2016
Actual Study Completion Date :
Dec 26, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conjugated Estrogen Group

use of 1 gram per day

Drug: Promestriene
use of 1 gram per day
Other Names:
  • Colpotrofine
  • Drug: Estriol
    use of 1 gram per day
    Other Names:
  • Stelle
  • Drug: Vaginal Moisturizer - Cream
    use of 1 gram per day
    Other Names:
  • Vagidrat
  • Active Comparator: Promestriene Group

    use of 1 gram per day

    Drug: Conjugated Estrogen
    use of 1 gram per day
    Other Names:
  • Premarin
  • Drug: Estriol
    use of 1 gram per day
    Other Names:
  • Stelle
  • Drug: Vaginal Moisturizer - Cream
    use of 1 gram per day
    Other Names:
  • Vagidrat
  • Active Comparator: Estriol Group

    use of 1 gram per day

    Drug: Conjugated Estrogen
    use of 1 gram per day
    Other Names:
  • Premarin
  • Drug: Promestriene
    use of 1 gram per day
    Other Names:
  • Colpotrofine
  • Drug: Vaginal Moisturizer - Cream
    use of 1 gram per day
    Other Names:
  • Vagidrat
  • Placebo Comparator: Vaginal Moisturizer Cream

    use of 1 gram per day

    Drug: Conjugated Estrogen
    use of 1 gram per day
    Other Names:
  • Premarin
  • Drug: Promestriene
    use of 1 gram per day
    Other Names:
  • Colpotrofine
  • Drug: Estriol
    use of 1 gram per day
    Other Names:
  • Stelle
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluate the histopathological effects on endometrium after each treatment [48 days]

      Compare the histopathological results after treatment on each group and among each other

    2. Compare the endometrial thickness measured by ultrassound after each treatment [48 days]

      Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other

    Secondary Outcome Measures

    1. Evaluate the changes of maturation index (Meisels Index) after each treatement [48 days]

      Compare the changes on Meisels Index after each treatment and among each other

    2. Evaluate the changes on climacteric complaints after each treatment [48 days]

      Compare the changes on systemic and genital complaints after each treatment, and among each other

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universidade Federal do ParanĂ¡

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elisa Chicareli Pinhat, Doctor, Universidade Federal do ParanĂ¡
    ClinicalTrials.gov Identifier:
    NCT03032848
    Other Study ID Numbers:
    • 23286013.7.0000.0096
    • 475.622
    First Posted:
    Jan 26, 2017
    Last Update Posted:
    May 1, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 1, 2019