Microbiological Impact of an Intimate Cream and Its Suitability to Contribute to the Feeling of Softness and Freshness in the Intimate Area of Women
Condition: Post Menopausal Dryness in the Intimate Area of Women
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The rational for using probiotics is that the humans are colonized by a numbers of
      microorganisms from birth. These microorganisms are the natural flora of the human body. This
      bacterial ecology may be imbalanced due different circumstances: excessive hygiene, use of
      antibiotics or other drugs, use of alcohol, smoking, stress, diabetes and many other factors.
      The natural bacterial flora in the external part of the genital tract might be promoted by
      help of intimate products containing probiotics.

      The study objectives 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 and at the end of a 10 days crème-usage (day 8-10), as well as 10 (9-11)
      days after finished crème-usage.

      The primary endpoint of the study Presence of at least one LN bacteria strain in the intimate
      area of women in the intervention group compared to the intimate area of women in the control
      group at the end of a 10 days crème-usage (Day 8-10), as well as 10 (9-11) days after
      finished crème-usage. The primary endpint will be measured by bacterial Culture.

      None-parametric statistical analyses.

      Secondary endpoints Obtain information about the coliform bacteria flora in respect to E.
      coli flora in the external intimate area before and at the end of the 10 days crème-usage
      (Day 8-10), as well as 10 days after finished crème-usage (9-11 days after).

      Obtain information about the subjective feeling of dryness and freshness in the intimate of
      women before and at the end of the 10 days crème-usage (Day 8-10), as well as 10 days after
      finished crème-usage (9-11 days after).

      Only descriptive statistics.

      Blinding The active and comparative test product will be filled into white tubes with
      identical appearance.

      The study will be conducted with double-blind design when neither the personnel at the clinic
      and the participants knows which product they are submitted/received. The study will also be
      blinded for the laboratory personnel analyzing the samples.

      Randomization procedure The women will be randomly assigned to active or comparative test
      products. Based on a computer-generated list, before start of the study, nine tubes
      containing Probiotic Intimate Crème (the active product) and 9 tubes containing Soothing
      crème (the control product) will be randomly assigned to a number between 1 to 18, and the
      tubes labeled with the numbers. The numbered but otherwise visually identical tubes will
      delivered to the clinic before start of the study.

      During the first visit, the participants will receive a tube consecutively in numerical
      order, as they are included in the study, i.e. according to their participant number.

      The computer-generated randomization list and the product labeling will be carried out by
      people who don't have direct contact with the study participants.

      Sample collection

      Vaginal samples:

      The samples will be taken by rolling sterile swabs over the upper third part of the lateral
      vaginal wall.

      Labial samples:

      For labial sampling, on the left side of the vulva near the vaginal orifice, the labia minor
      and major will be held apart and a sterile swab will be gently rubbed back and forth five
      times during rotation. The labial examination area will be approximately 2 cm2.

      The swabs will then be placed in a prepared transport medium and sent to laboratory for
      analyses.

      6.12. Study outline

      Visit 1:

        1. Women visiting the clinic will be recruited to the study. After obtained information
           (Appendix 1) and signed informed consent the women will be clinically examined for any
           clinical symptoms of Candida vaginitis (ocular examination) and bacterial vaginosis
           (Amsel's criteria). The dryness of the mucus membranes will be also examined and the
           vaginal pH measured using a pH-stick.

        2. Women fulfilling the inclusion criteria will be randomized to 10 days use of test
           product (Probiotic Intimate Crème) or control product (Soothing Cream, ACO); 2 times
           daily, every morning and evening at bed time.

        3. The women will receive detailed instructions about how to use the study products.

        4. They will also asked to return the empty tube or remaining product at the end of study
           (Visit 3)

        5. The women will answer a questioner regarding their subjective feeling of dryness and
           freshness in their intimate are and rate their feeling on a ten-point scale.

        6. Samples with sterile swabs will be collected from vagina, labia and perineum (Sample
           1-L, Sample 1-V) and sent to an independent laboratory for analyses.

      Visit 2:

        1. The 8th-10th day of the intimate crème-usage period, the women will return to the
           clinic. The dryness of their mucus membranes will be clinically examined and the vaginal
           pH.

        2. They will answer a questioner regarding their subjective feeling of dryness and
           freshness in their intimate are and rate their feeling on a on a ten-point scale. They
           will also answer questions regarding their purchase intentions and intentions to
           recommend the product to other women.

        3. Vaginal and labial swabs will be collected (Sample 2-L, Sample 2-V) and send to an
           independent laboratory for analyses.

      Visit 3:

        1. 9-11 days after the 10 days crème-usage period, the women will return to the clinic. The
           dryness of their mucus membranes will be clinically examined and the vaginal pH
           measured.

        2. They will answer a questioner regarding their subjective feeling of dryness and
           freshness in their intimate are and rate their feeling on a ten-point scale. They will
           also answer questions regarding their purchase intentions and intentions to recommend
           the product to other women.

        3. Vaginal and labial swabs will be collected. (Sample 3-L, Sample 3-V) and sent to an
           independent laboratory for analyses.

      During each visit, data will be recorded in the CRF.
    

Intervention name(s): probiotic creme; Placebo
Intervention type(s): Device; Drug
Intervention description(s): Probiotic creme applied; Creme without probiotics applied in same manner
Other intervention name(s): Ellen AB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: probiotic; post-menopausal; atrophic vaginitis