Vaginal Disease Clinical Trial
— HYDRAMUCOfficial title:
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
Verified date | December 2021 |
Source | Laboratoires IPRAD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | January 31, 2023 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
France | Chru Besancon - Site 002 | Besançon | |
France | Leon Berard - Site 007 | Lyon | |
France | Institut de Cancerologie de Lorraine - Site 004 | Nancy | |
France | Chu Nantes - Site 003 | Nantes | |
France | Chu Caremeau - Site 001 | Nîmes | |
France | Clinique Pasteur - Site 005 | Toulouse | |
France | Institut Gustave Roussy - Site 006 | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Laboratoires IPRAD | Axonal-Biostatem, Créapharm, Institut Alfred Fournier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
3 Months | |
Secondary | 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) |
3 Months | |
Secondary | Time to additional local treatment administration | 3 Months | ||
Secondary | 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 | 3 Months | |
Secondary | 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) |
3 Months | |
Secondary | 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) |
3 Months | |
Secondary | Vaginal flora composition (Nugent score) evolution | Measured on vaginal sample collected at inclusion, 1 month and 3 months | 3 Months | |
Secondary | Complications and adverse events | Complications and adverse events related to study intervention | 3 Months | |
Secondary | 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" |
3 Months |
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