CompletedNot Applicable

Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes

Finland225 participantsStarted 2016-10

Plain-language 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.

Who can participate

Age range

25 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, 5 weeks

Change in vaginal and vulvar pH

Timeframe: Baseline, 5 weeks

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

Timeframe: Baseline, 5 weeks

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

Timeframe: Baseline, 5 weeks

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

Timeframe: 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

Timeframe: Baseline, 5 weeks

Trial details

NCT IDNCT02937805

SponsorPetra Larmo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07

View on ClinicalTrials.gov More Vaginal Dryness trials

Plain-language summary

Who can participate

Age range

25 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline, 5 weeks

Change in vaginal and vulvar pH

Timeframe: Baseline, 5 weeks

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

Timeframe: Baseline, 5 weeks

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

Timeframe: Baseline, 5 weeks

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

Timeframe: Baseline, 5 weeks