Vulvovaginal AtrophyPhase 3NCT04232813
Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
A Phase 3 study testing Estradiol 10 MCG Vaginal Tablet [VAGIFEM] and Promestriene Vaginal in people with Vulvovaginal Atrophy, run by Instituto Palacios at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Estradiol 10 MCG Vaginal Tablet [VAGIFEM] and Promestriene Vaginal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2020to 30 Nov 2020
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
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 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 .
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Estradiol 10 MCG Vaginal Tablet [VAGIFEM], Promestriene Vaginal
- Keywords
- Vaginal dryness, Vaginal soreness, Vaginal irritation, Dyspareunia
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol 10 MCG Vaginal Tablet [VAGIFEM]Drug
To insert the tablets the patient must use the applicator provided in the way explained in the prospectus.
Promestriene VaginalDrug
To insert the cream the patient must use the applicator provided in the way explained in the prospectus.
| Study group | Role | What they receive |
|---|---|---|
| Estradiol 10 micrograms vaginal tablets | Active comparator | 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. Receives: Drug: Estradiol 10 MCG Vaginal Tablet [VAGIFEM] |
| Promestriene 10mg./g vaginal cream | Active comparator | 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. Receives: Drug: Promestriene Vaginal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vulvovaginal Symptoms
Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks
Measured: Change from Baseline, at week 4 and at week 12
Secondary outcomes (6)
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.
Measured: Change from Baseline, at week 4 and at week 12
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
Measured: Change from Baseline, at week 4 and at week 12
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.
Measured: Change from Baseline, at week 4 and at week 12
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.
Measured: Change from Baseline, at week 4 and at week 12
Occurrence of adverse events
Number of adverse events
Measured: Change from Baseline, at week 4 and at week 12
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
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 posted18 Jan 2020
- Study start9 Jan 2020
- Primary completion30 Jun 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective, monocentric, open-label, randomized, parallel-group study.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Palacios
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232813
- Sponsor's protocol ID
- IP-AVV2019
- Status last verified
- Feb 2021
- First submitted
- 10 Jan 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34813408
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
- Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
- ClinicalTrials.gov ID
- NCT04232813
- Acronym / sponsor ID
- IP-AVV2019
- Conditions
- Vulvovaginal Atrophy
- Keywords
- Vaginal dryness, Vaginal soreness, Vaginal irritation, Dyspareunia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto PalaciosUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 18 Jan 2020 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Prospective, monocentric, open-label, randomized, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Estradiol 10 micrograms vaginal tablets | Active comparator | Drug: Estradiol 10 MCG Vaginal Tablet [VAGIFEM]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. |
| Promestriene 10mg./g vaginal cream | Active comparator | Drug: Promestriene VaginalOne 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 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 .
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Estradiol 10 MCG Vaginal Tablet [VAGIFEM]To insert the tablets the patient must use the applicator provided in the way explained in the prospectus. | Drug | Estradiol 10 micrograms vaginal tablets |
| Promestriene VaginalTo insert the cream the patient must use the applicator provided in the way explained in the prospectus. | Drug | Promestriene 10mg./g vaginal cream |
Primary outcome
Vulvovaginal Symptoms
Time frame: Change from Baseline, at week 4 and at week 12
Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks
6 secondary outcomes
Evaluation of relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia.
Time frame: Change from Baseline, at week 4 and at week 12
Evaluation of changes in ph.
Time frame: Change from Baseline, at week 4 and at week 12
Evaluation of vaginal maturation index by Pap smear.
Time frame: Change from Baseline, at week 4 and at week 12
Evaluation of changes in soreness and irritation.
Time frame: Change from Baseline, at week 4 and at week 12
Occurrence of adverse events
Time frame: Change from Baseline, at week 4 and at week 12
Evaluation of endometrium thickness using vaginal ultrasound
Time frame: Change from Baseline, at week 4 and at week 12
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.
- Derived from this study: PubMed 34813408Palacios 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.
- Individual participant dataSharing planned: No
Related trials for Vulvovaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Estradiol 10 MCG Vaginal Tablet [VAGIFEM] and Promestriene Vaginal in people with Vulvovaginal Atrophy, run by Instituto Palacios at 1 site in Spain.
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 13 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 1 site in 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
On the ClinicalTrials.gov record for NCT04232813, which also lists 1 linked publication.
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.