Vulvar AtrophyNCT02966925
Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness
A study testing Cellular Matrix BCT-HA Kit in people with Vulvar Atrophy, run by Regen Lab SA at 1 site in France.
Trial summary
Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms of vaginal atrophy include dryness, itching, burning and dyspareunia. This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Vulvar Atrophy
- What is being tested?
- Cellular Matrix BCT-HA Kit
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Dec 2017
- Phase
- Interventional
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from vulvovaginal dryness who cannot benefit from hormonal therapy
- Patients having signed an Informed Consent
- Patient capable of understanding the study's imperatives
Who cannot join
- Vulvovaginal inflammation or infection
- History of vaginal herpes
- History of vulvar, vaginal or cervical cancer
- Lichen sclerosus
- History of allergy to HA
- Hereditary or acquired hematological or clotting disorders, such as drepanocytosis, platelet dysfunction, thrombocytopenia (150'000 platelets/µl)
Show all 12Show fewer
- Anemia (HGB ≤ 10g/dl)
- Autoimmune disease (Hashimoto, rheumatoid disease, lupus, etc.)
- HIV positive
- Hepatitis B or C
- Pregnancy or breastfeeding
- No contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Benefit of the Use of Platelet-Rich Plasma (PRP) Combined to Hyaluronic Acid (HA) for Vulvovaginal Dryness
Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms of vaginal atrophy include dryness, itching, burning and dyspareunia.
This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from reference treatments (hormonal therapies).To achieve this, 20 patients suffering from vulvovaginal dryness will be treated with one session of injections in the vulva, the posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal dryness will be primarily appreciated through Friedmann score and pH value, and secondarily through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6 months after the treatment.
Read the detailed description
A treatment relying on the association of both platelet-rich plasma (PRP) and hyaluronic acid (HA) could represent a therapeutical alternative for patients suffering from vulvovaginal dryness who cannot be treated with hormone therapy.
Indeed, hyaluronic acid is widely distributed in all tissues, and most particularly in vulvovaginal tissues. Due to its hydrating and healing properties, HA plays a key role in tissue regeneration, facilitating the entry of a large number and variety of cells into the injured area, reconstructing in this way an extracellular matrix capable of supporting the proliferation and differentiation of cells for tissue regeneration. In addition,its ability to retain water at up to 1000x its weight makes it the ideal substance for ensuring hydration of the skin. Thus, the gynaecological use of HA could be a promising therapeutic option for the treatment of vulvovaginal dryness.
On the other hand, numerous studies have shown the role of PRP in the healing of soft and hard tissues. PRP is an autologous preparation from the patient's own blood playing the role of growth factors reservoir during treatment. Indeed, platelet activation induces alpha-granules degranulation, releasing synthesized pre-packaged growth factors. Once released, growth factors induce different cell signaling cascades that activate angiogenesis, cell proliferation, cell differentiation and new matrix synthesis for tissue regeneration. A recent clinical study showed that PRP could significantly reduce sexual distress of patients suffering from dyspareunia and suggests that PRP could improve vaginal vascularization and physiologic responsivness in patients with vaginal atrophy.
In the present pilot study, a combination of PRP/HA obtained with Cellular Matrix will be injected in the vulva, vaginal wall and perineum of women with vulvovaginal dryness. Outcomes will be compared before and at various timepoints after treatment.
- Conditions
- Vulvar Atrophy
- Being tested
- Cellular Matrix BCT-HA Kit
- Keywords
- Vulvovaginal dryness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellular Matrix BCT-HA KitDevice
Submucosal injections in the vulva, in the posterior vaginal wall and in the perineum of a combination product made of PRP and HA prepared using the Cellular Matrix BCT-HA medical device
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Cellular Matrix | Experimental | Patients will be treated with a combination of PRP/HA prepared with Cellular Matrix BCT-HA Kit Receives: Device: Cellular Matrix BCT-HA Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal pH
Variation of the vaginal pH between baseline and Month 3 after treatment
Measured: 3 months
Friedmann score
Variation of the Friedmann score between baseline and Month 3 after treatment
Measured: 3 months
Secondary outcomes (3)
Female Sexual Distress (FSD) score
Variation of the FSD score between baseline and various timepoints after treatment
Measured: Month 1, Month 3 and Month 6
Female Sexual Function Index (FSFI) score
Variation of the FSFI score between baseline and various timepoints after treatment
Measured: Month 1, Month 3 and Month 6
Adverse device effects
Safety monitoring through the record of adverse device effects at Month 1, Month 3 and Month 6
Measured: Month 1, Month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionDec 2017
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- case-series
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regen Lab SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Méningaud, MD, Principal investigator, CHU Henri Mondor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966925
- Sponsor's protocol ID
- 2015-SM-001
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2016
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefit of the Use of Platelet-Rich Plasma (PRP) Combined to Hyaluronic Acid (HA) for Vulvovaginal Dryness
- ClinicalTrials.gov ID
- NCT02966925
- Acronym / sponsor ID
- 2015-SM-001
- Conditions
- Vulvar Atrophy
- Keywords
- Vulvovaginal dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Regen Lab SAIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- 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.
Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms of vaginal atrophy include dryness, itching, burning and dyspareunia.
This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from reference treatments (hormonal therapies).To achieve this, 20 patients suffering from vulvovaginal dryness will be treated with one session of injections in the vulva, the posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal dryness will be primarily appreciated through Friedmann score and pH value, and secondarily through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6 months after the treatment.
Detailed description
A treatment relying on the association of both platelet-rich plasma (PRP) and hyaluronic acid (HA) could represent a therapeutical alternative for patients suffering from vulvovaginal dryness who cannot be treated with hormone therapy.
Indeed, hyaluronic acid is widely distributed in all tissues, and most particularly in vulvovaginal tissues. Due to its hydrating and healing properties, HA plays a key role in tissue regeneration, facilitating the entry of a large number and variety of cells into the injured area, reconstructing in this way an extracellular matrix capable of supporting the proliferation and differentiation of cells for tissue regeneration. In addition,its ability to retain water at up to 1000x its weight makes it the ideal substance for ensuring hydration of the skin. Thus, the gynaecological use of HA could be a promising therapeutic option for the treatment of vulvovaginal dryness.
On the other hand, numerous studies have shown the role of PRP in the healing of soft and hard tissues. PRP is an autologous preparation from the patient's own blood playing the role of growth factors reservoir during treatment. Indeed, platelet activation induces alpha-granules degranulation, releasing synthesized pre-packaged growth factors. Once released, growth factors induce different cell signaling cascades that activate angiogenesis, cell proliferation, cell differentiation and new matrix synthesis for tissue regeneration. A recent clinical study showed that PRP could significantly reduce sexual distress of patients suffering from dyspareunia and suggests that PRP could improve vaginal vascularization and physiologic responsivness in patients with vaginal atrophy.
In the present pilot study, a combination of PRP/HA obtained with Cellular Matrix will be injected in the vulva, vaginal wall and perineum of women with vulvovaginal dryness. Outcomes will be compared before and at various timepoints after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case-series
| Arm | Type | Receives |
|---|---|---|
| Treatment with Cellular Matrix | Experimental | Device: Cellular Matrix BCT-HA KitPatients will be treated with a combination of PRP/HA prepared with Cellular Matrix BCT-HA Kit |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffering from vulvovaginal dryness who cannot benefit from hormonal therapy
- Patients having signed an Informed Consent
- Patient capable of understanding the study's imperatives
Key exclusion criteria (12 listed)
- Vulvovaginal inflammation or infection
- History of vaginal herpes
- History of vulvar, vaginal or cervical cancer
- Lichen sclerosus
- History of allergy to HA
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 |
|---|---|---|
| Cellular Matrix BCT-HA KitSubmucosal injections in the vulva, in the posterior vaginal wall and in the perineum of a combination product made of PRP and HA prepared using the Cellular Matrix BCT-HA medical device | Device | Treatment with Cellular Matrix |
Primary outcome
Vaginal pH
Time frame: 3 months
Variation of the vaginal pH between baseline and Month 3 after treatment
Friedmann score
Time frame: 3 months
Variation of the Friedmann score between baseline and Month 3 after treatment
3 secondary outcomes
Female Sexual Distress (FSD) score
Time frame: Month 1, Month 3 and Month 6
Female Sexual Function Index (FSFI) score
Time frame: Month 1, Month 3 and Month 6
Adverse device effects
Time frame: Month 1, Month 3 and Month 6
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 15 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Vulvar Atrophy
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Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
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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.
Jean-Paul Méningaud, MD principal investigator
CHU Henri Mondor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellular Matrix BCT-HA Kit in people with Vulvar Atrophy, run by Regen Lab SA at 1 site in France.
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 3 inclusion and 12 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 15 Nov 2019. 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 France. 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?
Vaginal pH (time frame: 3 months). The study lists 2 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 15 Nov 2019.