open label, active-controlled, randomized, parallel group, comparative study.
This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene citrate treatment. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Seoul National University Hospital Institutional Review Board
Seoul, South Korea
The ovulation rate after 3 cycles of the injection
Time frame: 5 weeks maximum
Total dose used, IU (International Unit)
Time frame: 5 weeks
Duration of stimulation, days
Time frame: 5 weeks
Threshold dose, IU
Time frame: 5 weeks
Number of follicles
Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter
Time frame: 5 weeks
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