Doppelblindstudie zur Wirksamkeit von Ovula mit 0,2 mg und 0,03 mg Estriol im Vergleich zu Placebo bei vaginaler Atrophie

• Conditions: vaginal atrophy; MedDRA version: 9.1Level: LLTClassification code 10047782Term: Vulvovaginal atrophy

• Registration Number: EUCTR2008-003382-22-DE
• Lead Sponsor: Dr. Kade Pharmazeutische Fabrik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-18
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- clinical diagnosis of vaginal atrophy
- age = 18
- postmenopausal female subjects
- PAP not older than 6 months
- vaginal maturation index (VMI) < 40%
- at least one symptom of vaginal atrophy should be = 65 on visual analog scale (VAS)
- vaginal pH > 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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- increase of VMI<br>- decrease of the vaginal pH<br>- improvement of the most disturbing symptom (decrease on the VAS)<br>