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

NCT02162160 | Completed Phase 2

• 1 other identifier: KI DS 2013
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Menopausal Dryness in the Intimate Area of Women

Keywords

probiotic; post-menopausal; atrophic vaginitis

Outcome Measures

Primary Outcomes (1)

• Presence of at least one LN bacteria strain in the intimate area of women in the intervention group

  Bacterial Culture of LN bacterial strains

  the end of a 10 days crème-usage

Secondary Outcomes (2)

• Obtain information about the coliform bacteria flora in respect to E. coli flora in the external intimate area

  at the end of creme usage and 10 days after finished crème-usage (9-11 days after).

• subjective feeling of dryness and freshness in the intimate of women

  the end of the 10 days crème-usage (Day 8-10) and 10 days after finished crème-usage (9-11 days after)

Study Arms (2)

Probiotic creme

EXPERIMENTAL

Women receing probiotic creme

Device: probiotic creme

placebo

PLACEBO COMPARATOR

Women receiving a moisturizer

Drug: Placebo

Interventions

probiotic creme DEVICE

Probiotic creme applied

Also known as: Ellen AB

Probiotic creme

Placebo DRUG

Creme without probiotics applied in same manner

placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Dept of Obstetrics and Gynecology, Dnderyds Hospital

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Atrophic Vaginitis

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Helena Kopp Kallner, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MD, PhD

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: June 12, 2014
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

SE (1)