Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Microbiological Impact of an Intimate Cream and Its Suitability to Contribute to the Feeling of Softness and Freshness in the Intimate Area of Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162160
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Helena Kopp Kallner, Karolinska Institutet

Brief Summary:

Generate more information on the use of the Probiotic Intimate Crème regarding feeling of dryness and freshness in the intimate area, as well as to evaluate the Lactobacillus flora and presence of coliform bacteria in respect to E. coli in the intimate area of women before use of the crème and at the end of a 10 days crème-usage (day 8-10), as well as 10 days after (9-11 days) finished crème-usage.

The hypothesis is that lactobacilli can survive in the intimate area of postmenopausal women with use of a probiotic creme.


Condition or disease Intervention/treatment Phase
Post Menopausal Dryness in the Intimate Area of Women Device: probiotic creme Drug: Placebo Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Microbiological Impact of a Cream and the Feeling of Softness and Freshness in the Intimate Area of Women
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Probiotic creme
Women receing probiotic creme
Device: probiotic creme
Probiotic creme applied
Other Name: Ellen AB

Placebo Comparator: placebo
Women receiving a moisturizer
Drug: Placebo
Creme without probiotics applied in same manner




Primary Outcome Measures :
  1. Presence of at least one LN bacteria strain in the intimate area of women in the intervention group [ Time Frame: the end of a 10 days crème-usage ]
    Bacterial Culture of LN bacterial strains


Secondary Outcome Measures :
  1. Obtain information about the coliform bacteria flora in respect to E. coli flora in the external intimate area [ Time Frame: at the end of creme usage and 10 days after finished crème-usage (9-11 days after). ]
    Measured by bacterial Culture and subtyping by PCR

  2. subjective feeling of dryness and freshness in the intimate of women [ Time Frame: the end of the 10 days crème-usage (Day 8-10) and 10 days after finished crème-usage (9-11 days after) ]
    Assessed through self adminstered questionnair with grading of feeling of dryness and freshness on a scale from 0 (no dryness and feeling fresh) to 5 (max dryness and absolutely not feeling fresh)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • healthy women 45-65 years old
  • with subjective dryness in the intimate area
  • postmenopausal with last menstruation more than or equal to 3 years prior to entering the study
  • being willing to abstain sexual intercourse during the study period

Exclusion Criteria:

  • yeast infection or bacterial vaginosis
  • use of antibiotics or antifungals
  • use of estrogen
  • participation in Another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162160


Locations
Layout table for location information
Sweden
Dept of Obstetrics and Gynecology, Dnderyds Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Helena Kopp Kallner, MD, PhD Karolinska Institutet
Layout table for additonal information
Responsible Party: Helena Kopp Kallner, Consultant, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02162160    
Other Study ID Numbers: KI DS 2013
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015
Keywords provided by Helena Kopp Kallner, Karolinska Institutet:
probiotic
post-menopausal
atrophic vaginitis