A multicenter, double-blind, randomized, cross-over study to investigate the efficacy of Gynodianâ Depot i.m. compared to 4 mg estradiol valerate i.m. both given every four weeks for five months combined with 5mg medroxyprogesterone acetate orally in postmenopausal women with impaired well-being, mood and sexuality
Project management at the University of Würzburg:
This clinical trial is designed as a multicenter, national, double-blind, randomized, cross-over study. The patients will receive either Gynodianâ Depot (combined with MPA, if applicable) or estradiol valerate (combined with MPA, if applicable) for the first five cycles and the other treatment for the following five cycles, respectively, depending on the treatment sequence.
A duration of treatment of at least 3 months is considered to be sufficient for symptom efficacy evaluation. The treatment periods of 5 months each, for Gynodian Depot and 4 mg estradiol valerate alone, is chosen according to the experience made in a previous study in which significant improvement in well-being occurred after four months of DHEA treatment.
The psychometric tests and rating scales used in this study (MRS II, SCL-90-R, GBB-24, HADS and VAS) are short and precise instruments for measuring patient progress during treatment. They are validated measurements to evaluate psychological symptoms in patients and are appropriate to be used in postmenopausal women. These psychometric tests should be assessed within the days 7-14 after the last i.m. injection and not in the phase of progestogen application to get the test results in a steady-state situation as far as hormone kinetics is concerned.
Projekt period: from 05.2002 to 03.2004
Wirtschaftsunternehmen ( Schering AG )
Open-label study to evaluate the pharmacokinetics of hormonal steroids in postmenopausal women after a single injection of Gy