A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®

A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome

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.

Inclusion Criteria:

• WHO group II
• Clomiphene citrate resistance
• BMI: 17~29 kg/m^2
• Irregular menstrual cycle
• Normal blood concentration of FSH, E2, prolactin and TSH

Exclusion Criteria:

• Uncontrolled endocrine disease
• Ovarian cystic tumor which are NOT related to PCOS
• Severe endometriosis
• Chronic cardiovascular disease, liver complaint