Clinical Trial: A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome
Brief Summary: 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.
Detailed Summary:
Sponsor: Dong-A Pharmaceutical Co., Ltd.
Current Primary Outcome: The ovulation rate after 3 cycles of the injection [ Time Frame: 5 weeks maximum ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 [ Time Frame: 5 weeks ]Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter
Original Secondary Outcome: Same as current
Information By: Dong-A ST Co., Ltd.
Dates:
Date Received: March 18, 2013
Date Started: January 2007
Date Completion:
Last Updated: March 26, 2013
Last Verified: March 2013
