Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Primary Purpose
Vulvovaginal Atrophy
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Estradiol 10 MCG Vaginal Tablet [VAGIFEM]
Promestriene Vaginal
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring Vaginal dryness, Vaginal soreness, Vaginal irritation, Dyspareunia
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.
Sites / Locations
- Instituto Palacios
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Estradiol 10 micrograms vaginal tablets
Promestriene 10mg./g vaginal cream
Arm 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.
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.
Outcomes
Primary Outcome Measures
Vulvovaginal Symptoms
Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks
Secondary Outcome Measures
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.
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
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.
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.
Occurrence of adverse events
Number of adverse events
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
Full Information
NCT ID
NCT04232813
First Posted
January 10, 2020
Last Updated
February 10, 2021
Sponsor
Instituto Palacios
Collaborators
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT04232813
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Palacios
Collaborators
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
Keywords
Vaginal dryness, Vaginal soreness, Vaginal irritation, Dyspareunia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A Prospective, monocentric, open-label, randomized, parallel-group study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Estradiol 10 micrograms vaginal tablets
Arm Type
Active Comparator
Arm 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.
Arm Title
Promestriene 10mg./g vaginal cream
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Estradiol 10 MCG Vaginal Tablet [VAGIFEM]
Intervention Description
To insert the tablets the patient must use the applicator provided in the way explained in the prospectus.
Intervention Type
Drug
Intervention Name(s)
Promestriene Vaginal
Intervention Description
To insert the cream the patient must use the applicator provided in the way explained in the prospectus.
Primary Outcome Measure Information:
Title
Vulvovaginal Symptoms
Description
Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks
Time Frame
Change from Baseline, at week 4 and at week 12
Secondary Outcome Measure Information:
Title
Evaluation of relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia.
Description
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.
Time Frame
Change from Baseline, at week 4 and at week 12
Title
Evaluation of changes in ph.
Description
Percentage of women with changes in pH at Visit 1 and Visit 2 compared to Screening Visit. Comparison with the two groups
Time Frame
Change from Baseline, at week 4 and at week 12
Title
Evaluation of vaginal maturation index by Pap smear.
Description
Percentage of woman with changes in vaginal maturation index by Pap smear at Visit 2 compared to Screening Pap smear and comparison between groups.
Time Frame
Change from Baseline, at week 4 and at week 12
Title
Evaluation of changes in soreness and irritation.
Description
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.
Time Frame
Change from Baseline, at week 4 and at week 12
Title
Occurrence of adverse events
Description
Number of adverse events
Time Frame
Change from Baseline, at week 4 and at week 12
Title
Evaluation of endometrium thickness using vaginal ultrasound
Description
Percentage of women with changes in endometrium thickness at Visit 2 compared to Screening Visit and comparison between groups
Time Frame
Change from Baseline, at week 4 and at week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Instituto Palacios
City
Madrid
ZIP/Postal Code
28009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34813408
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.
Results Reference
derived
Learn more about this trial
Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
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