Status:
COMPLETED
A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Infertility
Anovulation
Eligibility:
FEMALE
20-38 years
Phase:
PHASE3
Brief Summary
open label, active-controlled, randomized, parallel group, comparative study.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Uncontrolled endocrine disease
- Ovarian cystic tumor which are NOT related to PCOS
- Severe endometriosis
- Chronic cardiovascular disease, liver complaint
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01820728
Start Date
January 1 2007
End Date
October 1 2012
Last Update
April 15 2021
Active Locations (1)
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1
Seoul National University Hospital Institutional Review Board
Seoul, South Korea, 110-744