Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer. (HYDRAMUC)

Laboratoires IPRAD

Status: Unknown

Conditions: Vaginal Disease

Treatments: Device: Mucogyne® ovule

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04664985

IPR_HYDRAMUC_17

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Mucogyne®

Active Comparator group

Description:

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.

Treatment:

Device: Mucogyne® ovule

Control

No Intervention group

Description:

No treatment for this arm.