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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-06

Study Completion Date

2023-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Vaginal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mucogyne®

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.

Group Type ACTIVE_COMPARATOR

Mucogyne® ovule

Intervention Type DEVICE

hyaluronic acid, vaginal ovule

Control

No treatment for this arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mucogyne® ovule

hyaluronic acid, vaginal ovule

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No