Vulvovaginal AtrophyNCT03385551
Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
An observational study of Vulvovaginal Atrophy, run by Instituto Palacios at 2 sites in 2 countries.
Trial summary
This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Estradiol
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Dec 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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
Read the 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
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Estradiol
- Keywords
- Vulvovaginal Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Also called Promestriene
Estradiol or Promestriene depending on the arm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Estradiol | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Vulvovaginal Symptoms
Dispareunya, dryness, itching nd burning
Measured: Change from Baseline, at week 4 and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start9 Dec 2019
- Primary completion30 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santiago Palacios, MD, Principal investigator, Instituto Palacios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385551
- Sponsor's protocol ID
- IP-AVV2017
- Status last verified
- Feb 2021
- First submitted
- 30 Nov 2017
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
- ClinicalTrials.gov ID
- NCT03385551
- Acronym / sponsor ID
- IP-AVV2017
- Conditions
- Vulvovaginal Atrophy
- Keywords
- Vulvovaginal Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto PalaciosUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | – | Drug: EstradiolPatients 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 |
| 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Women who had a known or suspected history of breast carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstradiolAlso: PromestrieneEstradiol or Promestriene depending on the arm | Drug | ARM 1 |
Primary outcome
Vulvovaginal Symptoms
Time frame: Change from Baseline, at week 4 and at week 12
Dispareunya, dryness, itching nd burning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Palacios, MD principal investigator
Instituto Palacios
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvovaginal Atrophy, run by Instituto Palacios at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vulvovaginal Symptoms (time frame: Change from Baseline, at week 4 and at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.