Vulvar AtrophyPhase 4VIBRANCT04705883
Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors
A Phase 4 study testing Prasterone (DHEA), Micronized in people with Vulvar Atrophy and Breast Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY) Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vulvar Atrophy, Breast Cancer, Genitourinary Syndrome of Menopause
- What is being tested?
- Prasterone (DHEA), Micronized
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 1 Dec 2021
- Phase
- Phase 4
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breast cancer treated with anti-hormonal therapy based on inhibitors of aromatase (IA) (letrozole, anastrozole or exemestane) ± analogues of the GnRH (aGnRH)
- Menopause (natural or induced) and signs / symptoms of vulvovaginal atrophy
- Cytology and / or determination of Human Papillomavirus (HPV) negative
- Intention or willingness to have sex
Who cannot join
- To have received topical hormonal treatment in the last 6 months or Have used vaginal moisturizers and / or lubricants during the 30 days prior to the study treatment
- To have received treatment with laser, radiofrequency, hyaluronic acid, etc. in the vagina during the last two years at the beginning of the study
- To Have: an active infection of the genital tract; an intraepithelial neoplasm of the cervix, vagina or vulva; suspected of suffering or having been treated for cancer of the genital tract; suffer a genital prolapse of II degree or greater
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Prasterone In The Treatment Of Vaginal Atrophy In Patients With Breast Cancer Treatment With Aromatase Inhibitors (Vibra Study)
VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)
Read the detailed description
Verify a clinical improvement of AVV without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with aromatase inhibitors by administering vaginal prasterone.
- Being tested
- Prasterone (DHEA), Micronized
- Keywords
- Breast Cancer, Genitourinary Syndrome of Menopause
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasterone (DHEA), MicronizedDrug
Also called Intrarosa
Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.
| Study group | Role | What they receive |
|---|---|---|
| Prasterone | Other | 10 patients will be treated using prasterone during 6 months. Receives: Drug: Prasterone (DHEA), Micronized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estradiol
Ultrasensitive blood estradiol, serum levels measured in pg/ml
Measured: 12 months
Secondary outcomes (5)
Vaginal pH
vaginal pH measured by ph roll from 1 to 14 (the lesser the better)
Measured: 12 months
Vaginal maturation index
vaginal maturation index meadured by vaginal citology on percentage from 0 to 100 divided in superficial, intermediate and basal cells. The more superficial, the better.
Measured: 12 months
Vaginal health index
To describe if there is a correlation between changes in the visual examination of the vagina. using the vaginal health index: from 5 to 25 (min-max). The higher the better.
Measured: 12 months
Female Sexual Function Index
Questionaire from 18 to 90 (min-max). The higher the better.
Measured: 12 months
Social Functioning Questionnaire
Questionaire Social Functioning 12 (Physical and Mental Health Composite Scores) from 0 to 12 (min-max). The higher the better.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Sep 2020
- Primary completion8 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar AtrophyStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camil Castelo-Branco, Hospital Clinic of Barcelona
- Investigators
- Camil Castelo-Branco, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705883
- Sponsor's protocol ID
- Versión 4- 20/09/2020
- Acronym
- VIBRA
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2021
- Last updated
- 22 Feb 2022
- Results posted
- 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 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Prasterone In The Treatment Of Vaginal Atrophy In Patients With Breast Cancer Treatment With Aromatase Inhibitors (Vibra Study)
- ClinicalTrials.gov ID
- NCT04705883
- Acronym / sponsor ID
- VIBRA / Versión 4- 20/09/2020
- Keywords
- Breast Cancer, Genitourinary Syndrome of Menopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 Jan 2021 (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.
VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)
Detailed description
Verify a clinical improvement of AVV without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with aromatase inhibitors by administering vaginal prasterone.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prasterone | Other | Drug: Prasterone (DHEA), Micronized10 patients will be treated using prasterone during 6 months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer treated with anti-hormonal therapy based on inhibitors of aromatase (IA) (letrozole, anastrozole or exemestane) ± analogues of the GnRH (aGnRH)
- Menopause (natural or induced) and signs / symptoms of vulvovaginal atrophy
- Cytology and / or determination of Human Papillomavirus (HPV) negative
- Intention or willingness to have sex
Key exclusion criteria (3 listed)
- To have received topical hormonal treatment in the last 6 months or Have used vaginal moisturizers and / or lubricants during the 30 days prior to the study treatment
- To have received treatment with laser, radiofrequency, hyaluronic acid, etc. in the vagina during the last two years at the beginning of the study
- To Have: an active infection of the genital tract; an intraepithelial neoplasm of the cervix, vagina or vulva; suspected of suffering or having been treated for cancer of the genital tract; suffer a genital prolapse of II degree or greater
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 |
|---|---|---|
| Prasterone (DHEA), MicronizedAlso: IntrarosaVaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration. | Drug | Prasterone |
Primary outcome
Estradiol
Time frame: 12 months
Ultrasensitive blood estradiol, serum levels measured in pg/ml
5 secondary outcomes
Vaginal pH
Time frame: 12 months
Vaginal maturation index
Time frame: 12 months
Vaginal health index
Time frame: 12 months
Female Sexual Function Index
Time frame: 12 months
Social Functioning Questionnaire
Time frame: 12 months
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 22 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Vulvar Atrophy
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
Active, not recruiting
Laser Vaginal Treatment for GSM
Menopausal Urethral Atrophy, Vulvar Atrophy
Recruiting
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Not yet recruiting
Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting
Vulvar Lichen Sclerosus, Vulvar Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
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.
Camil Castelo-Branco principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasterone (DHEA), Micronized in people with Vulvar Atrophy and Breast Cancer, run by Hospital Clinic of Barcelona 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 4 inclusion and 3 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 22 Feb 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Estradiol (time frame: 12 months). 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 22 Feb 2022.