Vulvovaginal AtrophyPhase 3ROSANCT04898556
Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
A Phase 3 study testing Prasterone 6.5 MG in people with Vulvovaginal Atrophy, run by Dr. Santiago Palacios at 1 site in Spain.
Trial summary
A prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / or vestibular pain. 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?
- Prasterone 6.5 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 22 Dec 2020to 30 Jun 2021
- 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
- Women over 45 years of age with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.
- Women with moderate to severe vulvar / vestibular pain
- Women without symptoms or signs of acute vaginal infection.
- Women without symptoms of urinary infection and a negative urine strip result.
- Woman willing to carry out the study procedures and comply with the visits.
- Woman who signs the Informed Consent.
Who cannot join
- Hormone treatment in the last three months for vulvovaginal atrophy
- Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
- Laser treatment in the last 6 months.
- Acute and recurrent urinary tract infections in the last 3 months.
- Acute genital infections (herpes, candida, etc)
- Personal history of cancer at any level
Show all 17Show fewer
- Present alterations in the area to be treated, such as lacerations, abrasions or ulcers (resolution time at the medical discretion)
- Decompensated non-communicable chronic diseases (Diabetes Mellitus, Heart Disease ...)
- Participation in a clinical study 3 months before inclusion or during this study.
- Hypersensitivity to the active principle or any of the excipients
- Undiagnosed vaginal bleeding.
- Untreated endometrial hyperplasia
- Acute liver disease or a history of liver disease while liver function tests remain impaired.
- Current diagnosis or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism)
- Known thrombophilic disorders (protein C, protein S, or antithrombin deficiency)
- Current or recent diagnosis of arterial thromboembolic disease (angina, myocardial infarction)
- Porphyria
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Instituto Palacios
Madrid, 28009
Santiago Palacios, PI, +34 91 578 05 17, investigacion@institutopalacios.com
Marieta Ramirez, SI, +34 91 578 05 17, investigacion@institutopalacios.com
About this study
A prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / or vestibular pain. The efficacy of Prasterone treatment is evaluated in those patients willing to undergo the treatment compared to the control group.
Read the detailed description
A sample of 50 women over 45 years of age with at least one year of amenorrhea and who require treatment for vulvovaginal atrophy of moderate and / or severe intensity and who present vulvar and vaginal pain within these symptoms will be chosen.
At the beginning of the study, after passing the selection criteria and signing the informed consent, the patients will be randomly assigned to one of the two arms of the study, (active group) or (control group), said assignment will be made randomly. Through a computer program where one or the other arm of treatment will be assigned to the patient at random to guarantee the homogeneity of both study groups and thus avoid selection biases.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Prasterone 6.5 MG, Placebo
- Keywords
- Vultar/vestibular pain, Dyspareunia, Vaginal dryness
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasterone 6.5 MGDrug
Also called Active Treatment
The dose to be applied will be one Intrarosa ovule (Prasterone 6.5mg) a day before going to bed for 12 weeks.
PlaceboOther
Also called Control Group
Patients with a diagnosis of VVA who will not undergo treatment for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Patients who will undergo treatment with Intrarosa (Prasterone 6.5mg) in ovules, will apply one ovule a day before going to bed for 12 weeks. Receives: Drug: Prasterone 6.5 MG |
| Control Group | Placebo comparator | Patients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain.
Measured: Screening Visit 1 (Day 0)
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain.
Measured: Visit 2 (Week 4)
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain.
Measured: Visit 3 (Week 12)
Secondary outcomes (4)
Evaluation of vulvo vestibular pain
Through the visual analog scale (VAS)
Measured: Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12)
Evaluation of vulvovaginal vascularization
Through the ECO DOPPLER
Measured: Screening visit 1 (Day 0); Visit 3 (Week 12)
Evaluation of Ph and cytological maturity index
On the lateral side of the vagina we take the Ph sample through a strip, and the cytological maturity is taken through a swab to take a sample from the cervical area.
Measured: Screening Visit 1 (Day 0); Visit 3 (Week 12)
Evaluation of the clinical index of vulvar and vaginal health
It is carried out through a clinical parameter that takes into account humidity, hydration, elasticity, pH among others ...
Measured: Screening Visit 1 (Day 0); Visit 3 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start22 Dec 2020
- Primary completion1 May 2021
- Study completion30 Jun 2021 (estimated)
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, prospective, open, randomized and controlled clinical study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Santiago Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Santiago Palacios, Instituto Palacios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898556
- Sponsor's protocol ID
- IP-ROSA2020
- Other IDs
- 2020-004517-12
- Acronym
- ROSA
- Status last verified
- May 2021
- First submitted
- 9 Feb 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain
- ClinicalTrials.gov ID
- NCT04898556
- Acronym / sponsor ID
- ROSA / IP-ROSA2020
- Conditions
- Vulvovaginal Atrophy
- Keywords
- Vultar/vestibular pain, Dyspareunia, Vaginal dryness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dr. Santiago PalaciosUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 24 May 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.
A prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / or vestibular pain. The efficacy of Prasterone treatment is evaluated in those patients willing to undergo the treatment compared to the control group.
Detailed description
A sample of 50 women over 45 years of age with at least one year of amenorrhea and who require treatment for vulvovaginal atrophy of moderate and / or severe intensity and who present vulvar and vaginal pain within these symptoms will be chosen.
At the beginning of the study, after passing the selection criteria and signing the informed consent, the patients will be randomly assigned to one of the two arms of the study, (active group) or (control group), said assignment will be made randomly. Through a computer program where one or the other arm of treatment will be assigned to the patient at random to guarantee the homogeneity of both study groups and thus avoid selection biases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, prospective, open, randomized and controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Drug: Prasterone 6.5 MGPatients who will undergo treatment with Intrarosa (Prasterone 6.5mg) in ovules, will apply one ovule a day before going to bed for 12 weeks. |
| Control Group | Placebo comparator | Other: PlaceboPatients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women over 45 years of age with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.
- Women with moderate to severe vulvar / vestibular pain
- Women without symptoms or signs of acute vaginal infection.
- Women without symptoms of urinary infection and a negative urine strip result.
- Woman willing to carry out the study procedures and comply with the visits.
Key exclusion criteria (17 listed)
- Hormone treatment in the last three months for vulvovaginal atrophy
- Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
- Laser treatment in the last 6 months.
- Acute and recurrent urinary tract infections in the last 3 months.
- Acute genital infections (herpes, candida, etc)
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 6.5 MGAlso: Active TreatmentThe dose to be applied will be one Intrarosa ovule (Prasterone 6.5mg) a day before going to bed for 12 weeks. | Drug | Active Treatment |
| PlaceboAlso: Control GroupPatients with a diagnosis of VVA who will not undergo treatment for 12 weeks. | Other | Control Group |
Primary outcome
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
Time frame: Screening Visit 1 (Day 0)
Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain.
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
Time frame: Visit 2 (Week 4)
Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain.
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy
Time frame: Visit 3 (Week 12)
Clinical study to evaluate the efficacy of Prasterone treatment for vulvovaginal atrophy in postmenopausal women with vulvar / vestibular pain.
4 secondary outcomes
Evaluation of vulvo vestibular pain
Time frame: Screening Visit 1 (Day 0); Visit 2 (Week 4); Visit 3 (Week 12)
Evaluation of vulvovaginal vascularization
Time frame: Screening visit 1 (Day 0); Visit 3 (Week 12)
Evaluation of Ph and cytological maturity index
Time frame: Screening Visit 1 (Day 0); Visit 3 (Week 12)
Evaluation of the clinical index of vulvar and vaginal health
Time frame: Screening Visit 1 (Day 0); Visit 3 (Week 12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 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.
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 Prasterone 6.5 MG in people with Vulvovaginal Atrophy, run by Dr. Santiago 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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 2 Jun 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Santiago Palacios Palacios, PI (+34 91 578 05 17, ipalacios@institutopalacios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment for vulvar / vestibular pain for patients with vulvovaginal atrophy (time frame: Screening Visit 1 (Day 0)). The study lists 3 primary outcomes in all. 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 2 Jun 2021.