Last updated on March 2018

Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Postmenopause | Atrophy of Vagina
  • Age: Between 18 - 99 Years
  • Gender: Female

Inclusion Criteria:

  • Postmenopausal women (last menstrual period more than 12 months ago or having undergone bilateral ovariectomy)
  • Age 18 years
  • Diagnosis of moderate to severe vaginal atrophy at screening visit with VMI < 40% and vaginal pH > 5
  • At least one subjective symptom of vaginal atrophy (dryness, pain/burning sensation, pruritus, discharge, dyspareunia) related to a score of 65 on the visual analogue scale (VAS)
  • Indication for vaginal treatment with Gynoflor (100 million viable L. acidophilus KS 400 and estriol 30 mcg per application) for 6 weeks because of symptomatic vaginal atrophy after menopause: 1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday).
  • Informed consent as documented by signature

Exclusion Criteria:

  • Administration of any form of oral/transdermal hormone therapy (HT) or selective estrogen receptor modulators (SERM) or phytoestrogens within 2 months prior to entry into or during the study.
  • Any use of over-the-counter vaginal products within 1 week prior to and during entry the study.
  • Known hypersensitivity or allergy to the investigational product
  • Estrogen dependent malignancy
  • Undiagnosed genital bleeding
  • Active thromboembolism
  • Active vulvovaginal Candidiasis, Trichomonas vaginitis or bacterial vaginitis based on light microscopy of vaginal secretions, vaginal pH, whiff test and KOH preparation
  • Active sexually transmitted infections (STI) including herpes simplex viral infection, gonorrhoea and Chlamydia.
  • Active urinary tract infection.
  • Use of antiinfectives
  • Pessary-users
  • Immunocompromised patients including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents
  • Severe liver and/or kidney disease
  • Diabetes mellitus
  • Polyneuropathy
  • Skin disease, e.g. lichen planus, lichen sclerosus, contact dermatitis
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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