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Completed

NCT Number: NCT01820728

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

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

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Key information

Conditions

Infertility Adnexal Diseases Anovulation Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital Institutional Review Board

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-3801 Injection

Drug

Gonal-F®

Drug

Primary outcomes

  1. The ovulation rate after 3 cycles of the injection

    Time frame: 5 weeks maximum

Secondary outcomes

  1. Total dose used, IU (International Unit)

    Time frame: 5 weeks

  2. Duration of stimulation, days

    Time frame: 5 weeks

  3. Threshold dose, IU

    Time frame: 5 weeks

  4. Number of follicles

    Time frame: 5 weeks

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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2013
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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