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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

open label, active-controlled, randomized, parallel group, comparative study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.; Dong-A ST Co., Ltd.

Criteria

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