Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Vulvovaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385551
• Other study ID #: IP-AVV2017
• Status: Completed
• Start date: December 9, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2021
• Source: Instituto Palacios
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Intervention

Drug:
• Estradiol
Estradiol or Promestriene depending on the arm

Locations

Country	Name	City	State
Italy	IRCCS "S Matteo Foundation"	Pavia
Spain	Instituto Palacios	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Palacios

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vulvovaginal Symptoms	Dispareunya, dryness, itching nd burning	Change from Baseline, at week 4 and at week 12