Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Completed

• Conditions: Vulvovaginal Atrophy
• Interventions: Drug: Estradiol

• Registration Number: NCT03385551
• Lead Sponsor: Instituto Palacios

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2019-12-09
• Primary Completion: 2020-06-30
• Study Completion: 2020-09-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARM 1	Estradiol	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

Primary Outcome Measures

Name	Time	Method
Vulvovaginal Symptoms	Change from Baseline, at week 4 and at week 12	Dispareunya, dryness, itching nd burning

Trial Locations

Locations (2)

IRCCS "S Matteo Foundation"; 🇮🇹 Pavia, Italy

Instituto Palacios; 🇪🇸 Madrid, Spain