vaginal atrophy MedDRA version: 9.1 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy
Conditions
Interventions
Trade Name: OeKolp Ovula
Pharmaceutical Form: Suppository
INN or Proposed INN: Estriol
CAS Number: 50-27-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.03-
Pha
Sponsors
Dr. Kade Pharmazeutische Fabrik GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - clinical diagnosis of vaginal atrophy - age = 18 - postmenopausal female subjects - PAP not older than 6 months - vaginal maturation index (VMI) 5 - signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - use of HRT including pytoestrogens during last 12 weeks prior to trial - local vaginal application of hormones during last 12 weeks prior to trial - known or suspected estrogens dependent malign tumour - PAP = III - endometrial thickness > 5 mm - known or suspected vaginal infection - known urinary tract infection - past or present breast cancer or suspicion of it - not clarified bleeding in genital area - existent venous thromboembolia - severe known renal insufficiency - known hypersensitivity to estriol or other ingredients - known or suspected drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: efficacy of vaginal suppositories containing 0,03 mg or 0,2 mg estriol in treatment of vaginal atrophy in comparison to placebo;Secondary Objective: safety and tolerability of vaginal suppositories containing 0,03 mg or 0,2 mg estriol in comparison to placebo;Primary end point(s): The primary end point is a combination of the following ponits: - increase of VMI - decrease of the vaginal pH - improvement of the most disturbing symptom (decrease on the VAS) | — |
Countries
Germany
Outcome results
None listed