HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2020-09-01

Brief Summary

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During postpartum and lactation, vaginal epithelium tends to have an impaired degree of hydration and lubrication. This may lead to vaginal dryness, burning sensation dyspareunia or itching, which negatively affect the sexual function of puerperal women.

This study aimed to evaluate the efficacy of HYDEAL-D® vaginal gel (HYALOGYN®, Fidia Farmaceutici, Abano Terme, Italy) application on promoting the restoration of sexual function in the postpartum period.

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Detailed Description

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Conditions

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Vagina; Anomaly Puerperium; Disease Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group receiving HYALOGYN®

Group Type EXPERIMENTAL

Vaginal gel HYALOGYN®

Intervention Type DRUG

Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks

Control group undergoing expectant management

Group Type PLACEBO_COMPARATOR

Expectant management

Intervention Type BEHAVIORAL

Expectant management for 12 consecutive weeks

Interventions

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Vaginal gel HYALOGYN®

Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks

Intervention Type DRUG

Expectant management

Expectant management for 12 consecutive weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women from 18 to 40 years old;
* Women in the puerperium period (after vaginal delivery or cesarean section);
* Women that are breast-feeding, that are not breast-feeding or that are breast-feeding partially;

Exclusion Criteria

* Allergy to hyaluronic acid gel;
* Women non-Italian speaking;
* Women with signs of vaginal infection;
* Women with a history of cancer of any site with recent genital bleeding of unknown origin; and patients with acute hepatopathy, embolic disorders, severe primary disease of kidney;
* Women who are attending or have attended other clinical trials within previous two weeks;
* Women with mental disorder and no insight

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes