Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04664985
Other study ID # IPR_HYDRAMUC_17
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 6, 2020
Est. completion date January 31, 2023

Study information

Verified date December 2021
Source Laboratoires IPRAD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

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)

Study Design


Intervention

Device:
Mucogyne® ovule
hyaluronic acid, vaginal ovule

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
Laboratoires IPRAD Axonal-Biostatem, Créapharm, Institut Alfred Fournier

Country where clinical trial is conducted

France, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT04245358 - Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara® N/A
Completed NCT04327947 - Evaluation of Gynecological Acceptability of 3 Health Care Products N/A
Recruiting NCT05587283 - Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women Phase 1
Completed NCT05888116 - Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness N/A
Not yet recruiting NCT00890487 - Hyaluronic Acid and Vaginal Distress N/A
Completed NCT04362371 - Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara N/A
Completed NCT05817292 - Study of the Vaginal Microbiota in Women Under Fertile Age
Completed NCT05872178 - Omegia Softgel Clinical Research Program N/A
Completed NCT04245293 - Clinical Trial Study To Evaluate The Performance And Safety Of Ainara® N/A