NCT02937805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

October 11, 2016

Last Update Submit

June 29, 2018

Conditions

Vaginal DrynessVaginal AtrophyVulvar DrynessVulvar Atrophy

Outcome Measures

Primary Outcomes (6)

  • 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 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

    From baseline to 5 weeks

Study Arms (3)

Moisturizing vaginal and vulvar sea buckthorn oil cream

EXPERIMENTAL

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

Device: Moisturizing vaginal and vulvar sea buckthorn oil cream

Moisturizing vaginal and vulvar cream

ACTIVE COMPARATOR

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

Device: Moisturizing vaginal and vulvar cream

Control

NO INTERVENTION

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

Interventions

Moisturizing vaginal and vulvar sea buckthorn oil creamDEVICE
Moisturizing vaginal and vulvar sea buckthorn oil cream
Moisturizing vaginal and vulvar creamDEVICE
Moisturizing vaginal and vulvar cream

Eligibility Criteria

Age25 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turun Gynekologikeskus

Turku, 20100, Finland

Location

Study Officials

  • Risto Erkkola, Professor

    Turun Gynekologikeskus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
R&D Manager

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 19, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

July 2, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)