Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Instituto Palacios

Status and phase: Completed; Phase 3

Conditions: Vulvovaginal Atrophy

Treatments: Drug: Promestriene Vaginal; Drug: Estradiol 10 MCG Vaginal Tablet [VAGIFEM]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04232813

IP-AVV2019

Details and patient eligibility

About

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).

Enrollment: 120 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Estradiol 10 micrograms vaginal tablets

Active Comparator group

Description:

One tablet intravaginally once daily for two weeks. Thereafter one tablet twice per week with at least a 3-days interval between treatments to maintain therapeutic response.

Treatment:

Drug: Estradiol 10 MCG Vaginal Tablet [VAGIFEM]

Promestriene 10mg./g vaginal cream

Active Comparator group

Description:

One application once daily intravaginally for two weeks. Thereafter one application twice per week with at least a 3-days interval between treatments to maintain therapeutic response.

Treatment:

Drug: Promestriene Vaginal