Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02269826
Other study ID # LB-04/2007
Secondary ID
Status Completed
Phase N/A
First received October 14, 2014
Last updated February 16, 2018
Start date February 2008
Est. completion date December 2008

Study information

Verified date February 2018
Source Dr. August Wolff GmbH & Co. KG Arzneimittel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The purpose of the study was to test the non-inferiority of the medical device Vagisan® Moisturising Cream (VMC) in comparison to Gynomunal® vaginal gel (GVG) in 6 centres in 120 women who suffered from "vaginal dryness". The main objective criterion was to compare the sum of 4 subjective symptoms of "vaginal dryness" measured daily over a period of 28 days. VMC should be applied daily, while GVG had to be administered daily during the first week and twice weekly thereafter.

The main objective parameter for efficacy analysis was the sum of the subjective symptoms of vaginal dryness (feeling of dryness, itching, burning sensation and pain) before, during (patient diaries) and after the 28-day therapy period.

The per-protocol analysis and of the intent-to-treat analysis should prove non-inferiority of VMC compared to GVG, despite a possible carry-over effect to the detriment of VMC. To avoid the problem of any possible carry-over effect the analysis of the first period was chosen for the primary comparison of both products.

Furthermore, objective symptoms of vaginal dryness detected via colposcopy, the vaginal secretion's pH, the efficacy assessment by the patients and the treating doctor and patients' questionnaires with regard to the product characteristics of the medical devices should be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- Therapy with antibiotics, steroids (excluding sexual steroids in oral, dermal or transdermal application) or antimycotics in the last 14 days before inclusion and participation in this study.

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Vagisan® Moisturising Cream
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
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).

Locations

Country Name City State
Germany Dr. med. Axel Gerick Aachen
Germany Dr. med. Julia Wanke Aachen
Germany Dr. med. Kirsten Grunwald Aachen
Germany Dr. med. Ralf Conrads Aachen
Germany Wolfgang Clemens Stolberg
Germany Anja Obermeyer Würselen

Sponsors (1)

Lead Sponsor Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses • Descriptive account of the per patient intraindividually determined total score consisting of the evaluations of the objective "vaginal dryness" diagnoses made by the investigator during the visits (thinning of the epithelium, redness, petechial bleeding, discharge, each rated as 0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced). 28 days
Secondary Patients' individual subjective symptoms of "vaginal dryness" Descriptive account of the patients' individual subjective symptoms of "vaginal dryness" expressed during the visits (feeling of dryness, itching, burning sensation and pain). 28 days
Secondary Overall efficacy and tolerability assessments The overall efficacy and tolerability assessments (investigator and/or patient) with the ratings "very good", "good", "satisfactory" and "poor". 28 days
Secondary Occurrence of side effects The assessment of one-sided 95% confidence intervals for the occurrence of side effects when using the test and reference medical device 28 days
Secondary Assessment of adverse events The assessment of adverse events that have not been classified as related to the medical device. 28 days
Secondary Vaginal pH Descriptive account of the vaginal pH as determined by the investigator during the visits. 28 days
Secondary Patients' subjective satisfaction with the test and reference medical device The patients' subjective satisfaction with the test and reference medical device based on a patient questionnaire conducted at the end of each treatment period [feeling of skin (within approximately 10 minutes of application and the following morning), discharge the next morning, stickiness, spreadability on the vulva (perivaginal), cooling effect, softness of the medical device, fragrance, handling of the applicator, overall assessment by the sexual partner] with ratings from 1 (very positive) to 6 (very negative) or 0=no assessment (see chapter 9.1.6 "Patient questionnaire"). 28 days
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01170195 - Effectiveness of Licorice Extract Dietary Supplement on the Treatment of Postmenopausal Symptoms Phase 1/Phase 2
Withdrawn NCT03666819 - Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy Phase 2
Completed NCT02937805 - Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes N/A
Completed NCT02994342 - Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness N/A
Recruiting NCT05913479 - Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer N/A
Completed NCT03307044 - Fractional CO2 Laser Therapy for Survivors of Breast Malignancies N/A
Recruiting NCT03714581 - Laser Therapy Following Radiotherapy for Gynecological Cancer N/A
Completed NCT01948583 - Humectant Activity of a New Formulation of Gynomunal® Vaginalgel Phase 4
Completed NCT03178825 - Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause N/A
Completed NCT03372720 - Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors N/A
Not yet recruiting NCT06282614 - Performance and Safety of MUCOGYNE® Ovule as a Moisturizer N/A
Completed NCT02176083 - Reproductive Health Survivorship Care Plan Pilot N/A
Completed NCT04908124 - A Clinical Investigation Into the Effectiveness and Safety of Five Water Based Personal Lubricants. Phase 3
Not yet recruiting NCT05156502 - To Assess Signs and Symptoms in Women Affected by GSM After One Cycle of Pixel CO2-Alma Fractionated Laser N/A
Completed NCT02638337 - Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause Phase 3
Not yet recruiting NCT02987647 - Perception of Efficacy, Safety and Tolerability of Three Non-hormonal Intravaginal Gels and Hormone Cream Phase 4
Not yet recruiting NCT03782961 - Evaluation of Viscosity of a Vaginal Moisturizer Phase 4
Completed NCT01697345 - Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy Phase 0
Withdrawn NCT01724242 - Vaginal DHEA for Women After Breast Cancer Phase 2/Phase 3
Completed NCT05644444 - Effectiveness and Safety of a Water-based and a Silicone-based Personal Lubricants With Sensory Action N/A