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Completed

NCT Number: NCT03032848

Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

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.

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Key information

Conditions

Vaginitis Atropic Atrophic Vaginitis Endometrial Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Urogenital Diseases Uterine Diseases Vaginal Diseases Vaginitis

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conjugated Estrogen

Drug

use of 1 gram per day

Other names: Premarin

promestriene

Drug

use of 1 gram per day

Other names: Colpotrofine

estriol

Drug

use of 1 gram per day

Other names: Stelle

Vaginal Moisturizer - Cream

Drug

use of 1 gram per day

Other names: Vagidrat

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Federal do Paraná

Other

Registry information

Official study title

Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2017
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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