Trial | NCT01820728  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    93
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 Started
Jan 31
2007
Primary Completion
Oct 31
2012
Study Completion
Oct 31
2012
Last Update
Apr 15
2021

Drug DA-3801 Injection

Drug Gonal-F®

DA-3801 injection Experimental

Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days

Gonal-F® Active Comparator

75 IU/day is injected for 14 days

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
No Results Posted