Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Aromtech

Status: Completed

Conditions: Vaginal Atrophy; Vaginal Dryness; Vulvar Dryness; Vulvar Atrophy

Treatments: Device: Moisturizing vaginal and vulvar cream; Device: Moisturizing vaginal and vulvar sea buckthorn oil cream

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02937805

MCMM

Details and patient eligibility

About

Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen. Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of intimate area. The objective of this study is to investigate the effects of a non-hormonal moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.

Enrollment: 225 patients

Sex: Female

Ages: 25 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Symptoms of vaginal dryness, burning or itching
• Symptom severity at least moderate

Exclusion criteria

• Systemic hormonal replacement therapy during the last 12 months
• Local hormonal replacement therapy during the last 4 weeks
• Known allergy to ingredients of the study creams
• Pregnancy
• Breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

Moisturizing vaginal and vulvar sea buckthorn oil cream

Experimental group

Description:

Moisturizing non-hormonal vaginal and vulvar cream containing sea buckthorn oil as active ingredient (medical device product in development). Administered twice or once per day for 5 weeks. Post-menopausal women n= 55 + 45. Pre-menopausal women n=15

Treatment:

Device: Moisturizing vaginal and vulvar sea buckthorn oil cream

Moisturizing vaginal and vulvar cream

Active Comparator group

Description:

Moisturizing non-hormonal vaginal and vulvar cream (commercial medical device cream already on the market, not containing sea buckthorn oil). Administered once - twice per day for 5 weeks. Postmenopausal women n=55

Treatment:

Device: Moisturizing vaginal and vulvar cream

Control

No Intervention group

Description:

No moisturizing vaginal and vulvar cream for 5 weeks. Postmenopausal women n=55