Vaginal DiseaseHYDRAMUCNCT04664985
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
A study testing Mucogyne® ovule in people with Vaginal Disease, run by Laboratoires IPRAD at 7 sites in France.
Trial summary
Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Vaginal Disease
- What is being tested?
- Mucogyne® ovule
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesFrance
- Study dates
- 6 Oct 2020to 31 Jan 2023
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman over 18
- hysterectomized patient with endometrial cancer (stage I, stage II and histological type I, without chemotherapy, with brachytherapy and/or radiotherapy) OR patient with cervical cancer (stage IA2 and IB1 with emboli or positive lymphadenopathy and IB2 stages with or without chemotherapy, with brachytherapy and / or radiotherapy)
- Only for patients with cervical cancer, premenopausal and non-hysterectomized: patient on contraception at least one month before V0 and throughout the study
- Only for patients with cervical cancer: complete remission
- Patient capable of receiving and understanding information related to the study, giving informed written consent, and easily completing a quality of life questionnaire
- Patient affiliated to the French social security system
Who cannot join
- Patient with clinically observed vulvovaginal infections
- Patient with endometrial cancer treated with chemotherapy
- Patient already participating in another study
- Patient under legal protection, or under guardianship or curatorship
- Only for patients with cervical cancer: local treatment with estrogen
- Only for patients with cervical cancer, premenopausal and non-hysterectomized: pregnancy (pregnancy test to be performed at V0)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Chru Besancon - Site 002
Besançon, 25000
Leon Berard - Site 007
Lyon, 69373
Institut de Cancerologie de Lorraine - Site 004
Nancy, 54519
Chu Nantes - Site 003
Nantes, 44093
Chu Caremeau - Site 001
Nîmes, 30029
Clinique Pasteur - Site 005
Toulouse, 31076
Institut Gustave Roussy - Site 006
Villejuif, 94805
About this study
Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.
- Conditions
- Vaginal Disease
- Being tested
- Mucogyne® ovule
- Keywords
- vaginal dryness
- Medical subject headings
- Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucogyne® ovuleDevice
hyaluronic acid, vaginal ovule
| Study group | Role | What they receive |
|---|---|---|
| Mucogyne® | Active comparator | The dosage during the study will be 1 Mucogyne® ovule per day at bedtime for 10 days and then 1 ovule every 2 days until the end of the 3-month follow-up. Receives: Device: Mucogyne® ovule |
| Control | No intervention | No treatment for this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Health Index (VHI) change from inclusion to end of study
Each parameter is evaluated from 1 (worst) to 5 (best/normal):
- vaginal elasticity,
- vaginal secretion volume,
- vaginal pH,
- epithelial mucous membrane integrity,
- vaginal hydration/lubrication.
The sum of points for each parameter gives the VHI, from 5 (worst) to 25 (best/normal)
Measured: 3 Months
Secondary outcomes (8)
Vaginal mucosa scarring evolution
Evolution of scarring of the vaginal mucosa by a composite score:
- visualization of the hysterectomy scar (not visible / visible) for endometrial cancer patients OR visualization of the cervix (not visible / visible) for cervical cancer patients,
- presence or absence of vaginal adhesions / cohalescences (walls and bottom of the vagina ),
- collapse of adhesions to touch (Y / N),
- edema / redness of vaginal mucosa (indicative of inflammation),
- pain caused by pressure (Y / N),
- bleeding caused by contact (none / moderate / severe)
Measured: 3 Months
Time to additional local treatment administration
Measured: 3 Months
Patient Global Impression of Change (PGIC) on vaginal health
Auto-evaluation: score from 1 (very much improved) to 7 (very much worse) on vaginal health related to the study intervention
Measured: 3 Months
Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution
Auto-evaluation of the symptoms: pain, dyspareunia, vaginal pruritis, vulvovaginal dryness on Visual Analogic Scale (VAS) of 10mm
Patient indicates where she locates the intensity of the symptom from 0mm (no symptom) to 10mm (worst intensity)
Measured: 3 Months
VHI change at each visit
Each parameter is evaluated from 1 (worst) to 5 (best/normal):
- vaginal elasticity,
- vaginal secretion volume,
- vaginal pH,
- epithelial mucous membrane integrity,
- vaginal hydration/lubrication. The sum of points for each parameters gives the VHI, from 5 (worst) to 25 (best/normal)
Measured: 3 Months
Vaginal flora composition (Nugent score) evolution
Measured on vaginal sample collected at inclusion, 1 month and 3 months
Measured: 3 Months
Complications and adverse events
Complications and adverse events related to study intervention
Measured: 3 Months
Patient satisfaction questionnaire at the end of study
All patients (both arms) will be asked about their satisfaction on the treatment of their vulvogainal symptoms during the study will be assessed using a 5-point Likert scale :
"At the end of this study, how would you rate your level of satisfaction with the treatment of your vulvovaginal symptoms? Very satisfactory / Satisfactory / Moderate / Poor / Very Poor"
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start6 Oct 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 80 women with endometrial cancer or Cervical cancer will be recruited over 8 months, 40 being randomized in the Mucogyne® arm, the 40 others in the control arm.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires IPRAD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Créapharm, Institut Alfred Fournier, Axonal-Biostatem
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664985
- Sponsor's protocol ID
- IPR_HYDRAMUC_17
- Acronym
- HYDRAMUC
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
- ClinicalTrials.gov ID
- NCT04664985
- Acronym / sponsor ID
- HYDRAMUC / IPR_HYDRAMUC_17
- Conditions
- Vaginal Disease
- Keywords
- vaginal dryness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Laboratoires IPRADIndustry (pharma, biotech, devices)
- Collaborators
- Créapharm, Institut Alfred Fournier, Axonal-Biostatem
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 11 Dec 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.
Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 80 women with endometrial cancer or Cervical cancer will be recruited over 8 months, 40 being randomized in the Mucogyne® arm, the 40 others in the control arm.
| Arm | Type | Receives |
|---|---|---|
| Mucogyne® | Active comparator | Device: Mucogyne® ovuleThe dosage during the study will be 1 Mucogyne® ovule per day at bedtime for 10 days and then 1 ovule every 2 days until the end of the 3-month follow-up. |
| Control | No intervention | –No treatment for this arm. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman over 18
- hysterectomized patient with endometrial cancer (stage I, stage II and histological type I, without chemotherapy, with brachytherapy and/or radiotherapy) OR patient with cervical cancer (stage IA2 and IB1 with emboli or positive lymphadenopathy and IB2 stages with or without chemotherapy, with brachytherapy and / or radiotherapy)
- Only for patients with cervical cancer, premenopausal and non-hysterectomized: patient on contraception at least one month before V0 and throughout the study
- Only for patients with cervical cancer: complete remission
- Patient capable of receiving and understanding information related to the study, giving informed written consent, and easily completing a quality of life questionnaire
Key exclusion criteria (6 listed)
- Patient with clinically observed vulvovaginal infections
- Patient with endometrial cancer treated with chemotherapy
- Patient already participating in another study
- Patient under legal protection, or under guardianship or curatorship
- Only for patients with cervical cancer: local treatment with estrogen
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 |
|---|---|---|
| Mucogyne® ovulehyaluronic acid, vaginal ovule | Device | Mucogyne® |
Primary outcome
Vaginal Health Index (VHI) change from inclusion to end of study
Time frame: 3 Months
Each parameter is evaluated from 1 (worst) to 5 (best/normal): * vaginal elasticity, * vaginal secretion volume, * vaginal pH, * epithelial mucous membrane integrity, * vaginal hydration/lubrication. The sum of points for each parameter gives the VHI, from 5 (worst) to 25 (best/normal)
8 secondary outcomes
Vaginal mucosa scarring evolution
Time frame: 3 Months
Time to additional local treatment administration
Time frame: 3 Months
Patient Global Impression of Change (PGIC) on vaginal health
Time frame: 3 Months
Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution
Time frame: 3 Months
VHI change at each visit
Time frame: 3 Months
Vaginal flora composition (Nugent score) evolution
Time frame: 3 Months
Complications and adverse events
Time frame: 3 Months
Patient satisfaction questionnaire at the end of study
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucogyne® ovule in people with Vaginal Disease, run by Laboratoires IPRAD at 7 sites 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 6 inclusion and 6 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 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
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 Health Index (VHI) change from inclusion to end of study (time frame: 3 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 3 Jan 2022.