Clinical trial NCT03385551: Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Official title: Observational Study to Evaluate the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvovaginal Atrophy
Keywords: Vulvovaginal Atrophy
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

Eligibility criteria: 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.

Primary outcomes:
measure: Vulvovaginal Symptoms
timeFrame: Change from Baseline, at week 4 and at week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS "S Matteo Foundation"
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
affiliation: Instituto Palacios
name: Santiago Palacios, MD
role: PRINCIPAL_INVESTIGATOR
References: