Efficacy and Safety of Non-hormonal Vaginal Preparations in Treating Vaginal Dryness

NCT02269826 | Completed

• 1 other identifier: LB-04/2007
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 6

Brief Summary

Vulvovaginal irritation due to dryness is a frequent complaint among post- and some premenopausal women. International guidelines recommend non-hormonal products as first line therapy. Efficacy and safety of the medical device Vagisan® Moisturising Cream (VMC), a non-hormonal vaginal cream for the treatment of vulvovaginal dryness and Gynomunal Vaginal Gel (GVG), a non-hormonal gel should be compared in a 12-week multicentre, open-label, randomised, two-period cross-over phase III trial. The hypothesis was that VMC is non-inferior to GVG. The primary endpoint was the sum of subjective symptoms of vulvovaginal atrophy (VVA) added up over each treatment period. Furthermore, objective symptoms of VVA and adverse effects were planned to be assessed. 120 women should be randomly allocated to either of the two treatments, each given over a period of 4 weeks.

Conditions

Vaginal Dryness

Outcome Measures

Primary Outcomes (1)

• per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain)

  The main objective criterion for the confirmatory analysis was the per patient intraindividually determined total score consisting of the patients' subjective symptoms (feeling of dryness, itching, burning sensation and pain, each rated as 0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced) during the course of therapy. This was based on the daily entry in the patient diary.

  Therapy period of 28 days

Secondary Outcomes (7)

• Intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses

  28 days

• Patients' individual subjective symptoms of "vaginal dryness"

  28 days

• Overall efficacy and tolerability assessments

  28 days

• Occurrence of side effects

  28 days

• Assessment of adverse events

  28 days

Study Arms (2)

Vagisan® Moisturising Cream

EXPERIMENTAL

non-hormonal vaginal cream for the treatment of vulvovaginal dryness

Device: Vagisan® Moisturising Cream

Gynomunal® vaginal gel

ACTIVE COMPARATOR

non-hormonal gel

Device: Gynomunal® vaginal gel

Interventions

Vagisan® Moisturising Cream DEVICE

Once in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application).

Also known as: WO 2085

Vagisan® Moisturising Cream

Gynomunal® vaginal gel DEVICE

Once in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application).

Gynomunal® vaginal gel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over the age of 18.
• Women with vaginal dryness who do not want to or are not allowed to use oestrogens, such as post-menopausal women, women with oestrogen-dependent tumours in their medical history and women who had been treated with systemic medicinal products that can have a drying-out effect on the vaginal mucous membranes.
• Total score (0-16) of at least 3 of four subjective symptoms (feeling of dryness, itching, burning sensation and pain).
• Written declaration of consent for the voluntary participation in the study is present.

You may not qualify if:

• Known hypersensitivity to one of the ingredients of the test and/or reference medical device.
• Current vaginal infections.
• Recurring (i.e. at least 3) vaginal infections within the last 12 months.
• Additional (not study-related) treatment of vaginal dryness during the therapy phases.
• Women who are not able to participate properly in this study.
• Fertile women without sufficient contraceptive protection.
• Fertile women who are pregnant (positive HCG test) or breastfeeding.
• Current alcohol and/or drug abuse.
• Participation in another clinical study within the last four weeks and/or parallel participation in this study.

Sponsors & Collaborators

• Dr. August Wolff GmbH & Co. KG Arzneimittel: lead

Study Sites (6)

Dr. med. Kirsten Grunwald

Aachen, 52064, Germany

Location

Dr. med. Julia Wanke

Aachen, 52070, Germany

Location

Dr. med. Axel Gerick

Aachen, 52072, Germany

Location

Dr. med. Ralf Conrads

Aachen, 52078, Germany

Location

Wolfgang Clemens

Stolberg, 52222, Germany

Location

Anja Obermeyer

Würselen, 52146, Germany

Location

Related Publications (1)

• Stute P, May TW, Masur C, Schmidts-Winkler IM. Efficacy and safety of non-hormonal remedies for vaginal dryness: open, prospective, randomized trial. Climacteric. 2015;18(4):582-9. doi: 10.3109/13697137.2015.1036854. Epub 2015 May 22.

  PMID: 25845406 DERIVED

Study Officials

• Christoph Abels, Prof., MD

  Dr. August Wolff GmbH & Co. KG Arzneimittel

  STUDY DIRECTOR

• Klaus-Michael Grunwald, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 21, 2014
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)