- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03385551
Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
February 10, 2021 updated by: Instituto Palacios
Observational Study to Evaluate the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream
Study Overview
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
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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)
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ARM 1
Patients who have been prescribed by the physician within the standard clinical practice 10 micrograms of estradiol vaginal tablets.
One tablet intravaginally once daily for two weeks.
Thereafter one tablet twice per week with at least a 3-days interval between treatments
|
Estradiol or Promestriene depending on the arm
Other Names:
|
ARM 2
Patients who have been prescribed by the physician within the standard clinical practice promestriene 10mg./g
vaginal cream. 1 gr.
one application once daily intravaginally for two weeks.
Thereafter one application twice per week with at least a 3-days interval between treatments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vulvovaginal Symptoms
Time Frame: Change from Baseline, at week 4 and at week 12
|
Dispareunya, dryness, itching nd burning
|
Change from Baseline, at week 4 and at week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 9, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
November 30, 2017
First Submitted That Met QC Criteria
December 20, 2017
First Posted (Actual)
December 28, 2017
Study Record Updates
Last Update Posted (Actual)
February 11, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IP-AVV2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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