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NCT01820728 Clinical Trial

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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01820728
Other study ID # DA3801_CA_III (Version 5.1)
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2007
Est. completion date October 2012

Study information
Verified date April 2021
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 38 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DA-3801 Injection

• Gonal-F®

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Institutional Review Board Seoul

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The ovulation rate after 3 cycles of the injection 5 weeks maximum
Secondary Total dose used, IU (International Unit) 5 weeks
Secondary Duration of stimulation, days 5 weeks
Secondary Threshold dose, IU 5 weeks
Secondary Number of follicles Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter 5 weeks
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