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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01820728

Enrollment

Registered

2013-03-29

Start date

2007-01-31

Completion date

2012-10-31

Last updated

2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Anovulation

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

Interventions

DRUGDA-3801 Injection

DRUGGonal-F®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 38 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The ovulation rate after 3 cycles of the injection	5 weeks maximum

Secondary

Measure	Time frame	Description
Total dose used, IU (International Unit)	5 weeks	—
Duration of stimulation, days	5 weeks	—
Threshold dose, IU	5 weeks	—
Number of follicles	5 weeks	Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026