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| Name | Class |
|---|---|
| Créapharm | UNKNOWN |
| Institut Alfred Fournier | UNKNOWN |
| Axonal-Biostatem | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | No treatment for this arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucogyne® ovule | Device | hyaluronic acid, vaginal ovule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Health Index (VHI) change from inclusion to end of study | Each parameter is evaluated from 1 (worst) to 5 (best/normal):
The sum of points for each parameter gives the VHI, from 5 (worst) to 25 (best/normal) | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal mucosa scarring evolution | Evolution of scarring of the vaginal mucosa by a composite score:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chru Besancon - Site 002 | Besançon | 25000 | France | |||
| Leon Berard - Site 007 |
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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.
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| 3 Months |
| Time to additional local treatment administration | 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 | 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) | 3 Months |
| VHI change at each visit | Each parameter is evaluated from 1 (worst) to 5 (best/normal):
| 3 Months |
| Vaginal flora composition (Nugent score) evolution | Measured on vaginal sample collected at inclusion, 1 month and 3 months | 3 Months |
| Complications and adverse events | Complications and adverse events related to study intervention | 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" | 3 Months |
| Lyon |
| 69373 |
| France |
| Institut de Cancerologie de Lorraine - Site 004 | Nancy | 54519 | France |
| Chu Nantes - Site 003 | Nantes | 44093 | France |
| Chu Caremeau - Site 001 | Nîmes | 30029 | France |
| Clinique Pasteur - Site 005 | Toulouse | 31076 | France |
| Institut Gustave Roussy - Site 006 | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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