Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Sponsor
Instituto Palacios (Other)
Overall Status
Completed
CT.gov ID
NCT03385551
Collaborator
(none)
120
2
9.7
60
6.2

Study Details

Study Description

Brief Summary

This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream

Condition or Disease Intervention/Treatment Phase

Detailed Description

This is an observational, prospective, open-label, parallel-group study to evaluate the acceptability, efficacy, and preferences of postmenopausal women older than 45 between 10 micrograms of estradiol vaginal tablets vs promestriene vaginal cream

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study to Evaluate the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Actual Study Start Date :
Dec 9, 2019
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm Intervention/Treatment
ARM 1

Patients who have been prescribed by the physician within the standard clinical practice 10 micrograms of estradiol vaginal tablets. One tablet intravaginally once daily for two weeks. Thereafter one tablet twice per week with at least a 3-days interval between treatments

Drug: Estradiol
Estradiol or Promestriene depending on the arm
Other Names:
  • Promestriene
  • ARM 2

    Patients who have been prescribed by the physician within the standard clinical practice promestriene 10mg./g vaginal cream. 1 gr. one application once daily intravaginally for two weeks. Thereafter one application twice per week with at least a 3-days interval between treatments

    Outcome Measures

    Primary Outcome Measures

    1. Vulvovaginal Symptoms [Change from Baseline, at week 4 and at week 12]

      Dispareunya, dryness, itching nd burning

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Postmenopausal women aged 45 years or older. Women will be considered postmenopausal with more than 12 months since last menstrual period

    • Women who have been prescribed vaginal estradiol tablets or vaginal promestriene cream· Women who have read and signed the Informed Consent Form

    • Women with an intact uterus

    • One or more vaginal symptoms (dryness, soreness, irritation, dyspareunia) rated as moderate to severe. Symptoms are moderate if the patient needs a treatment and feels discomfort. Symptoms are severe if the patient needs a treatment, and feels such a degree of discomfort that this could severely impact the subject's daily activities

    • In case of doubt, blood estradiol concentration will be determined, and the subject will only be enrolled if the levels are equal to 30pg./ml. or less.

    Exclusion Criteria:
    • Women who had a known or suspected history of breast carcinoma

    • Estrogen dependent neoplasia. Women with a known, past or suscpected Estrogen-dependent malignant tumours such as endormetrial or ovarian cancer

    • Positive or suspicious mammogram results

    • Any systemic malignant disease

    • Hormone therapy treatment (sex hormones or vaginal treatments or steroids) in the last three months Women who had abnormal vaginal bleeding or uterine bleeding of unknown cause

    • Vaginal infection requiring treatment

    • Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) Untreated endometrial hyperplasia Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency) Active or previous arterial thromboembolic disease (e.g. angina, myocardial infarction) Acute liver disease, or history of liver disease as long as liver function tests have failed to return to normal Known Hypersensitivity to the active substances or to any of the excipients Porphyria

    • Any serious disease or chronic condition that could interfere with study compliance

    • History of thrombolytic disorders

    • Use of vaginal contraceptives (DIU, vaginal ring…)

    • Participation in another clinical trial in the last three months.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS "S Matteo Foundation" Pavia Italy
    2 Instituto Palacios Madrid Spain 28009

    Sponsors and Collaborators

    • Instituto Palacios

    Investigators

    • Principal Investigator: Santiago Palacios, MD, Instituto Palacios

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Instituto Palacios
    ClinicalTrials.gov Identifier:
    NCT03385551
    Other Study ID Numbers:
    • IP-AVV2017
    First Posted:
    Dec 28, 2017
    Last Update Posted:
    Feb 11, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Instituto Palacios
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2021