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Completed

NCT Number: NCT03385551

Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

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

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Key information

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS "S Matteo Foundation", Pavia, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Estradiol

Drug

Estradiol or Promestriene depending on the arm

Other names: Promestriene

Primary outcomes

  1. Vulvovaginal Symptoms

    Time frame: Change from Baseline, at week 4 and at week 12

    Dispareunya, dryness, itching nd burning

Sponsors and collaborators

Lead sponsor

Instituto Palacios

Other

Registry information

Official study title

Observational Study to Evaluate the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 28, 2017
Registry last updated
Feb 11, 2021

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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