Trial document




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  DRKS00006888

Trial Description

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Title

Post Market Clinical Follow-up study of the use of the vaginal cream Remifemin® FeuchtCreme (RFC)

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Trial Acronym

SB-VMP 0212

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URL of the Trial

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Brief Summary in Lay Language

Remifemin® FeuchtCreme (RFC) is a CE-marked, innovative medical device (CE 0481) used in the treatment of patients with vaginal dryness. The cream is used in the vagina and on the skin of the outer genital area. It is applied with or without applicator. Details on the ingredients (including nurturing lipids and hamamelis water) and the mode of action (moisturizing and nurturing) of Remifemin® FeuchtCreme are described extensively in the instructions for use. It is the aim of this non-interventional study to document experiences with Remifemin® FeuchtCreme in a large patient population with vaginal dryness. The examination for the assessment of vaginal dryness and of the symptoms is part of normal routine just as the observation of possible adverse reactions in the course of treatment with a medication or medical device is. The use of a diary for the documentation of the applications by the patient as well as the use of standardized case report forms in all participating medical practices serve to investigate the safety, function, and user satisfaction with the usual therapeutic use of Remifemin® FeuchtCreme.

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Brief Summary in Scientific Language

Since October 2014, Remifemin® FeuchtCreme, an innovative, nurturing vaginal cream with hamamelis is available. The area of application can be summarized as follows:
- For complaints due to dryness of the vagina and the outer genital area (dry feeling, burning sensation, pain during sexual intercourse, or itching), as developed, for example, during the menopause.
- For the facilitation of sexual intercourse.
- For the physical support of the healing process of minor wounds and small inflammations of the vaginal skin.
As part of the Post Market Clinical Follow-Up Plan (PMCF plan) drawn up for Remifemin® FeuchtCreme, a PMCF study will be conducted now intended to observe the use of Remifemin® FeuchtCreme in a large patient population. The objective of a PMCF plan is to confirm the clinical performance and safety throughout the complete lifetime of the medical device and the acceptability of identified risks, and to detect emerging risks on the basis of factual evidence.
The study is a multicenter, open, non-interventional Post Market Clinical Follow-Up Study in physicians treating patients for vaginal dryness with Remifemin® FeuchtCreme (RFC).
Two visits will be documented in the scope of the Post Market Clinical Follow-Up Study: At Date 1 when Remifemin® FeuchtCreme is first prescribed, i.e. before start of therapy, and at Date 2 approx. 8 weeks after start of therapy. RFC is used discontinously as needed. Patient data collection consent must be obtained.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006888
  •   2014/10/20
  •   [---]*
  •   no
  •   Approved
  •   33/2014, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Complaints due to dryness of the vagina and the outer genital area (dry feeling, burning sensation, pain during sexual intercourse, or itching), as developed, for example, during the menopause.
  •   Facilitation of sexual intercourse.
  •   Physical support of the healing process of minor wounds and small inflammations of the vaginal skin.
  •   N89.8 -  Other specified noninflammatory disorders of vagina
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Interventions/Observational Groups

  •   Non-interventional study. Documentation of data of patients who are prescribed Remifemin® FeuchtCreme and use it discontinuously as needed (with or without applicator according to the instructions for use).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Change in physician assessment of vaginal moisture and change in subjective feeling of vaginal dryness (physician interviewing patient) on Date 2 (after approx. 8 weeks) as compared to the baseline value before start of therapy.

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Secondary Outcome

Change in subjective feeling of complaints and change in physician assessment of symptoms on Date 2 (after approx. 8 weeks) as compared to the baseline value before start of therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2014/10/22
  •   480
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- The use of the vaginal cream RFC for vaginal dryness is indicated.
- The vaginal cream RFC is used in line with the instructions for use.
- No restrictions on use of the vaginal cream RFC are recorded.
- Written data collection consent has been obtained.

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Exclusion Criteria

No

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Addresses

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    • Schaper & Brümmer GmbH & Co. KG
    • Bahnhofstraße 35
    • 38259  Salzgitter
    • Germany
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    • Frauenarztpraxis Salzgitter
    • Mr.  Dr. med.  Ralf-Peter  Schneeweis 
    • Mammutring 5
    • 38226  Salzgitter
    • Germany
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    •   05341 / 84 89 89-0
    •   05341 / 84 89 89-9
    •   DrSchneewe at aol.com
    •   [---]*
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    • Institut für angewandte Statistik Dr. Jörg Schnitker GmbH
    • Mr.  Dr. rer. nat.  Jörg  Schnitker 
    • Oberntorwall 16 – 18
    • 33602  Bielefeld
    • Germany
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    •   0521 / 56 088-0
    •   0521 / 56 088-70
    •   info at ias-cro.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Schaper & Brümmer GmbH & Co. KG
    • Bahnhofstraße 35
    • 38259  Salzgitter
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/14
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Trial Publications, Results and other Documents

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