Clinical trial NCT04232813: Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Official title: Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvovaginal Atrophy
Keywords: Vaginal dryness
Vaginal soreness
Vaginal irritation
Dyspareunia
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2020-01-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective, monocentric, open-label, randomized, parallel-group study.
Primary purpose: TREATMENT

Brief summary: Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation).


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 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.
* Blood estradiol concentration of 30 pg/ml or less .

Exclusion Criteria:

* Women who have not signed the Informed consent Form
* Women who had a known or suspected history of breast carcinoma
* Estrogen dependent neoplasia. Women with a known, past or suspected Estrogen-dependent malignant tumours such as endometrial 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:
measure: Evaluation of relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia.
timeFrame: Change from Baseline, at week 4 and at week 12
measure: Evaluation of changes in ph.
timeFrame: Change from Baseline, at week 4 and at week 12
measure: Evaluation of vaginal maturation index by Pap smear.
timeFrame: Change from Baseline, at week 4 and at week 12
measure: Evaluation of changes in soreness and irritation.
timeFrame: Change from Baseline, at week 4 and at week 12
measure: Occurrence of adverse events
timeFrame: Change from Baseline, at week 4 and at week 12
measure: Evaluation of endometrium thickness using vaginal ultrasound
timeFrame: Change from Baseline, at week 4 and at week 12
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
References:
citation: Palacios S, Ramirez M, Lilue M. Efficacy of low-dose vaginal 17beta-estradiol versus vaginal promestriene for vulvovaginal atrophy. Climacteric. 2022 Aug;25(4):383-387. doi: 10.1080/13697137.2021.1998436. Epub 2021 Nov 23.