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Humectant Activity of a New Formulation of Gynomunal® Vaginalgel (GYNOMUNAL®)

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ClinicalTrials.gov Identifier: NCT01948583
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : September 23, 2013
Sponsor:
Information provided by (Responsible Party):
Adele Sparavigna, Derming SRL

Brief Summary:
Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness

Condition or disease Intervention/treatment Phase
Vaginal Dryness Menopause Drug: Hyaluronic Acid Phase 4

Detailed Description:

Randomized, controlled, crossover clinical study; the subjects will use both formulations with an interval of 1 week (wash out period), in reversed sequence according to the treatment arm assigned at each subject during the basal visit.

Both tested products will be applied in the vagina, using the dedicated applicator, once a day, preferably at bedtime. To investigate the activity of the products under study, 4 visits will be performed: a baseline visit (T0), a visit at the end of the first week-treatment (T1), a visit at the end of the wash out period (T2) and a final visit at the end of the second week-treatment (T3).

Volunteers will be asked to follow their normal life and sexual habits, except for not having sexual intercourse 48 hours prior to each examination.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Humectant Activity of a New Formulation of Gynomunal® Vaginalgel: Crossover Test Use Versus Previous Formula
Study Start Date : May 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Active Comparator: Arm I: vaginal gel new formulation

Application once a day at evening during the first study week of the vaginal gel new formulation (hyaluronic acid).

One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal gel on the market (hyaluronic acid).

Drug: Hyaluronic Acid
Arm I: new formulation applied for the first week, formulation on the marked applied for the third week (second week - wash out period) Arm II: formulation on the marked applied for the first week, new formulation applied for the third week (second week - wash out period)
Other Name: Gynomunal® Vaginalgel (GYNOMUNAL®)

Active Comparator: Arm II: vaginal gel on the market

Application once a day at evening during the first study week of the vaginal gel on the market (hyaluronic acid).

One week of wash-out (second week). Application once a day at evening during the third study week of the vaginal new formulation (hyluronic acid).

Drug: Hyaluronic Acid
Arm I: new formulation applied for the first week, formulation on the marked applied for the third week (second week - wash out period) Arm II: formulation on the marked applied for the first week, new formulation applied for the third week (second week - wash out period)
Other Name: Gynomunal® Vaginalgel (GYNOMUNAL®)




Primary Outcome Measures :
  1. Vaginal Humidity determination [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Tolerability assessment [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian healthy female subjects,
  • complaining vaginal dryness,
  • women in menopause since at least 2 years; the starting period of menopause being defined as the date when the last menstruation or metrorragia linked to hormonal unbalance took place,
  • women who agree not to start a replacement therapy during the whole duration of the study,
  • women who do not present any active cutaneous pathology of external and internal genitalia,
  • women who did not receive any drug or cosmetic treatment on their genitalia during the 2 months preceding the trial,
  • women who did not apply vaginal products within at least 1 month before the inclusion in the study,
  • women who accept to use only the products authorised by the protocol,
  • women who accept not to undertake any treatment for internal and external genitalia during the trial,
  • women who did not use, phytoestrogenes based products on treated areas less than 4 weeks before inclusion time,
  • women accepting to sign the Informed consent form,
  • women able to read the material dedicated to volunteers, to abide by the rules of the protocol and ready to accept its constraints

Exclusion Criteria:

  • Volunteers not fulfilling inclusion criteria,
  • severe symptoms of vaginal dryness, associated with mucosal signs
  • history of intolerance to a vaginal product,
  • concomitant participation to another trial,
  • refusal to sign the Informed Consent form,
  • known allergy to one or several ingredients of the product on trial,
  • change in the normal habits in the last 3 months,
  • participation in a similar study during the previous 3 months,
  • whose insufficient adhesion to the study protocol is foreseeable
  • women who start a replacement therapy during the trial
  • women who experience during the study the occurrence of any foreseeable risk to use daily the product on trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948583


Locations
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Italy
DermIng S.r.l
Monza, MB, Italy, 20900
Sponsors and Collaborators
Derming SRL
Investigators
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Principal Investigator: Adele Sparavigna, Physician Derming SRL
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Responsible Party: Adele Sparavigna, Dermatologist, Derming SRL
ClinicalTrials.gov Identifier: NCT01948583    
Other Study ID Numbers: E0513
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013
Keywords provided by Adele Sparavigna, Derming SRL:
vaginal dryness
hyaluronic acid
menopause
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents