Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

NCT03385551 | Completed

• 1 other identifier: IP-AVV2017
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Vulvovaginal Atrophy

Keywords

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Vulvovaginal Symptoms

  Dispareunya, dryness, itching nd burning

  Change from Baseline, at week 4 and at week 12

Study Arms (2)

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

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

Interventions

Estradiol DRUG

Estradiol or Promestriene depending on the arm

Also known as: Promestriene

ARM 1

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Postmenopausal Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

120 postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Palacios: lead

Study Sites (2)

IRCCS "S Matteo Foundation"

Pavia, Italy

Location

Instituto Palacios

Madrid, 28009, Spain

Location

MeSH Terms

Interventions

Estradiol; promestriene

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Santiago Palacios, MD

  Instituto Palacios

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 28, 2017
• Study Start: December 9, 2019
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (1)