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Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

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ClinicalTrials.gov Identifier: NCT03032848
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Elisa Chicareli Pinhat, Universidade Federal do Paraná

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
Vaginitis Atropic Pelvic Organ Prolapse Endometrial Hyperplasia Drug: Conjugated Estrogen Drug: Promestriene Drug: Estriol Drug: Vaginal Moisturizer - Cream Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : November 26, 2013
Actual Primary Completion Date : December 20, 2016
Actual Study Completion Date : December 26, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conjugated Estrogen Group
use of 1 gram per day
Drug: Promestriene
use of 1 gram per day
Other Name: Colpotrofine

Drug: Estriol
use of 1 gram per day
Other Name: Stelle

Drug: Vaginal Moisturizer - Cream
use of 1 gram per day
Other Name: Vagidrat

Active Comparator: Promestriene Group
use of 1 gram per day
Drug: Conjugated Estrogen
use of 1 gram per day
Other Name: Premarin

Drug: Estriol
use of 1 gram per day
Other Name: Stelle

Drug: Vaginal Moisturizer - Cream
use of 1 gram per day
Other Name: Vagidrat

Active Comparator: Estriol Group
use of 1 gram per day
Drug: Conjugated Estrogen
use of 1 gram per day
Other Name: Premarin

Drug: Promestriene
use of 1 gram per day
Other Name: Colpotrofine

Drug: Vaginal Moisturizer - Cream
use of 1 gram per day
Other Name: Vagidrat

Placebo Comparator: Vaginal Moisturizer Cream
use of 1 gram per day
Drug: Conjugated Estrogen
use of 1 gram per day
Other Name: Premarin

Drug: Promestriene
use of 1 gram per day
Other Name: Colpotrofine

Drug: Estriol
use of 1 gram per day
Other Name: Stelle




Primary Outcome Measures :
  1. Evaluate the histopathological effects on endometrium after each treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 48 days ]
    Compare the changes on systemic and genital complaints after each treatment, and among each other



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Publications of Results:
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Responsible Party: Elisa Chicareli Pinhat, Doctor, Universidade Federal do Paraná
ClinicalTrials.gov Identifier: NCT03032848     History of Changes
Other Study ID Numbers: 23286013.7.0000.0096
475.622 ( Registry Identifier: Opinion Number )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperplasia
Prolapse
Pelvic Organ Prolapse
Vaginitis
Endometrial Hyperplasia
Atrophic Vaginitis
Pathologic Processes
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Uterine Diseases
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs