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

April 13, 2021 updated by: Dong-A ST Co., Ltd.

A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital Institutional Review Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DA-3801 injection
Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days
Drug: DA-3801 Injection
ACTIVE_COMPARATOR: Gonal-F®
75 IU/day is injected for 14 days
Drug: Gonal-F®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ovulation rate after 3 cycles of the injection
Time Frame: 5 weeks maximum
5 weeks maximum

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Eung Gi Min, M.D., Ph.D., Dongguk University Hospital
  • Principal Investigator: Chang Suk Suh, M.D., Ph.D., Seoul National University Bundang Hospital
  • Principal Investigator: Doo Seok Choi, M.D., Ph.D., Samsung Medical Center
  • Principal Investigator: Chung Hoon Kim, M.D., Ph.D., Asan Medical Center
  • Principal Investigator: Jong Min Park, M.D.,Ph.D., Gachon University Gil Medical Center
  • Principal Investigator: Kyung Joo Hwang, M.D., Ph.D., Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (ESTIMATE)

March 29, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA3801_CA_III (Version 5.1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on Gonal-F®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe