HYDEAL-D
Randomized Clinical Trial to Assess the Efficacy and Safety of HYDEAL-D® Application in Promoting the Restoration of Sexual Function in the Postpartum Period
Sponsor study identifier
interventional
25
1 country
1
Study Start
September 1, 2016
Actual (reported)Primary Completion
May 1, 2020
Actual (reported)Study Completion
September 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2016
Actual (reported)May 1, 2020
Actual (reported)September 1, 2020
Actual (reported)September 12, 2020
Actual (reported)September 23, 2020
Actual (reported)Evaluation of sexual function by FSFI
At baseline; 12 weeks
Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks
Expectant management for 12 consecutive weeks
Ospedale Policlinico San Martino
Genova, Italy
Gustavino C, Sala P, Cusini N, Gravina B, Ronzini C, Marcolin D, Vellone VG, Paudice M, Nappi R, Costantini S, Ferrero S, Barra F. Efficacy and safety of prolonged-release hyaluronic acid derivative vaginal application in the postpartum period: a prospective randomised clinical trial. Ann Med. 2021 Dec;53(1):1589-1597. doi: 10.1080/07853890.2021.1974083.
Fabio Barra, MD
Ospedale San Martino
25 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2020
First Posted
September 23, 2020
Study Start
September 1, 2016
Actual (reported)Daily Tadalafil on Body Fat and Lean Mass
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 1, 2020
Actual (reported)Study Completion
September 1, 2020
Actual (reported)Last Updated
January 18, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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