Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02937805

Enrollment

225

Registered

2016-10-19

Start date

2016-10-31

Completion date

2017-09-30

Last updated

2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Atrophy, Vaginal Dryness, Vulvar Atrophy, Vulvar Dryness

Brief summary

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.

Interventions

DEVICEMoisturizing vaginal and vulvar sea buckthorn oil cream

DEVICEMoisturizing vaginal and vulvar cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture	Baseline, 5 weeks
Change in vaginal and vulvar pH	Baseline, 5 weeks
Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist	Baseline, 5 weeks
Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist	Baseline, 5 weeks
Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist	Baseline, 5 weeks
Change in symptoms of vaginal and vulvar atrophy and dryness: symptom questionnaires; scoring from 0 to 3 dryness, burning, itching; VAS evaluation of mucosal dryness, irritation, soreness, pain during exercise, pain during intercourse	Baseline, 5 weeks

Secondary

Measure	Time frame
Change in symptoms of vaginal and vulvar atrophy and dryness: symptom logbooks; daily scoring from 0 to 3 dryness, burning, itching, pain, soreness, symptoms during intercourse	From baseline to 5 weeks

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026