Back to resultsA Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®
Primary Purpose
Infertility, Anovulation
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-3801 Injection
Gonal-F®
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility 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
Sites / Locations
- Seoul National University Hospital Institutional Review Board
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DA-3801 injection
Gonal-F®
Arm Description
Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days
75 IU/day is injected for 14 days
Outcomes
Primary Outcome Measures
The ovulation rate after 3 cycles of the injection
Secondary Outcome Measures
Total dose used, IU (International Unit)
Duration of stimulation, days
Threshold dose, IU
Number of follicles
Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01820728
Brief Title
A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Anovulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DA-3801 injection
Arm Type
Experimental
Arm Description
Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days
Arm Title
Gonal-F®
Arm Type
Active Comparator
Arm Description
75 IU/day is injected for 14 days
Intervention Type
Drug
Intervention Name(s)
DA-3801 Injection
Intervention Type
Drug
Intervention Name(s)
Gonal-F®
Primary Outcome Measure Information:
Title
The ovulation rate after 3 cycles of the injection
Time Frame
5 weeks maximum
Secondary Outcome Measure Information:
Title
Total dose used, IU (International Unit)
Time Frame
5 weeks
Title
Duration of stimulation, days
Time Frame
5 weeks
Title
Threshold dose, IU
Time Frame
5 weeks
Title
Number of follicles
Description
Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter
Time Frame
5 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eung Gi Min, M.D., Ph.D.
Organizational Affiliation
Dongguk University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang Suk Suh, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doo Seok Choi, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chung Hoon Kim, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Min Park, M.D.,Ph.D.
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyung Joo Hwang, M.D., Ph.D.
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital Institutional Review Board
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®
We'll reach out to this number within 24 hrs