Status:
COMPLETED
Efficacy of Gynodian® Depot in Women With Impaired Well-being
Lead Sponsor:
Bayer
Collaborating Sponsors:
Navitas Life Sciences GmbH
LKF Laboratory
Conditions:
Hormone Replacement Therapy
Eligibility:
FEMALE
45-65 years
Phase:
PHASE3
Brief Summary
The typical menopausal symptoms that are associated with a variety of physical and psychological changes (e.g. nervousness, anxiety, and depression) and also with impaired sexual interest and enjoymen...
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Eligibility Criteria
Inclusion
- Written informed consent
- Postmenopausal status (amenorrhea for at least 12 months)
- 45 - 65 years of age
- Application of estrogen or cyclic estrogen/progestin preparation other than the study medication for at least 6 months prior to Visit 1
- Relevant impairment of well-being and mood inspite of estrogen therapy (confirmed by questionnaire scores)
- BMI\<33kg/m2
Exclusion
- Uterine bleeding of unknown etiology within the last 2 years
- Previous or existing or suspected carcinoma of the breast
- Any malignant disease in the last 5 years
- Endometrial double layer thickness \> 5 mm
- History of thromboembolic events or existing thromboembolic processes
- Prior hormone replacement therapy with androgens within 12 months prior to Visit 1
- Major life events within the last 12 months prior to Visit 1
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00463450
Start Date
May 1 2002
End Date
April 1 2004
Last Update
December 30 2014
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