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OpenTrials
Completed

NCT Number: NCT02937805

Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

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.

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Key information

Conditions

Vaginal Dryness Vaginal Atrophy Vulvar Atrophy Vulvar Dryness

Age range

25 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Turun Gynekologikeskus

Turku, 20100, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moisturizing vaginal and vulvar sea buckthorn oil cream

Device

Moisturizing vaginal and vulvar cream

Device

Primary outcomes

  1. Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture

    Time frame: Baseline, 5 weeks

  2. Change in vaginal and vulvar pH

    Time frame: Baseline, 5 weeks

  3. Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist

    Time frame: Baseline, 5 weeks

  4. Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist

    Time frame: Baseline, 5 weeks

  5. Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist

    Time frame: Baseline, 5 weeks

  6. 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

    Time frame: Baseline, 5 weeks

Secondary outcomes

  1. 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

    Time frame: From baseline to 5 weeks

Sponsors and collaborators

Lead sponsor

Petra Larmo

Industry

Collaborators

  • The Finnish Funding Agency for Technology and Innovation
  • Turun Gynekologikeskus Oy

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 19, 2016
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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