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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01820728
Collaborator
(none)
93
Enrollment
1
Location
2
Arms
69
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2007
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

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®

Outcome Measures

Primary Outcome Measures

  1. The ovulation rate after 3 cycles of the injection [5 weeks maximum]

Secondary Outcome Measures

  1. Total dose used, IU (International Unit) [5 weeks]

  2. Duration of stimulation, days [5 weeks]

  3. Threshold dose, IU [5 weeks]

  4. Number of follicles [5 weeks]

    Counter the number of follicles which are 12 mm, 15 mm, 18 mm in diameter

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 38 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Institutional Review Board Seoul Korea, Republic of 110-744

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01820728
Other Study ID Numbers:
  • DA3801_CA_III (Version 5.1)
First Posted:
Mar 29, 2013
Last Update Posted:
Apr 15, 2021
Last Verified:
Apr 1, 2021
Additional relevant MeSH terms:
Infertility
Anovulation

Study Results

No Results Posted as of Apr 15, 2021