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

Vulvovaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232813
• Other study ID #: IP-AVV2019
• Status: Completed
• Phase: Phase 3
• Start date: January 9, 2020
• Est. completion date: November 30, 2020

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 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.

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Intervention

Drug:
• Estradiol 10 MCG Vaginal Tablet [VAGIFEM]
To insert the tablets the patient must use the applicator provided in the way explained in the prospectus.
• Promestriene Vaginal
To insert the cream the patient must use the applicator provided in the way explained in the prospectus.

Locations

Country	Name	City	State
Spain	Instituto Palacios	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Palacios	Novo Nordisk A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vulvovaginal Symptoms	Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks	Change from Baseline, at week 4 and at week 12
Secondary	Evaluation of relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia.	Percentage of women that verify a relief of atrophic vaginitis dryness, dyspareunia, soreness and irritation symptoms in the questionnaires provided at Visit 1 and Visit 2 compared to intensity of those symptoms at screening visit.	Change from Baseline, at week 4 and at week 12
Secondary	Evaluation of changes in ph.	Percentage of women with changes in pH at Visit 1 and Visit 2 compared to Screening Visit. Comparison with the two groups	Change from Baseline, at week 4 and at week 12
Secondary	Evaluation of vaginal maturation index by Pap smear.	Percentage of woman with changes in vaginal maturation index by Pap smear at Visit 2 compared to Screening Pap smear and comparison between groups.	Change from Baseline, at week 4 and at week 12
Secondary	Evaluation of changes in soreness and irritation.	Percentage of women that verify a relief of atrophic vaginitis dryness, dyspareunia, soreness and irritation symptoms in the questionnaires provided at Visit 1 and Visit 2 compared to intensity of those symptoms at screening visit.	Change from Baseline, at week 4 and at week 12
Secondary	Occurrence of adverse events	Number of adverse events	Change from Baseline, at week 4 and at week 12
Secondary	Evaluation of endometrium thickness using vaginal ultrasound	Percentage of women with changes in endometrium thickness at Visit 2 compared to Screening Visit and comparison between groups	Change from Baseline, at week 4 and at week 12