NCT01820728

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

5.8 years

First QC Date

March 18, 2013

Last Update Submit

April 13, 2021

Conditions

InfertilityAnovulation

Outcome Measures

Primary Outcomes (1)

  • The ovulation rate after 3 cycles of the injection

    5 weeks maximum

Secondary Outcomes (4)

  • Total dose used, IU (International Unit)

    5 weeks

  • Duration of stimulation, days

    5 weeks

  • Threshold dose, IU

    5 weeks

  • Number of follicles

    5 weeks

Study Arms (2)

DA-3801 injection

EXPERIMENTAL

Recominant human follicle stimulating hormone 75 IU/day is injected for 14 days

Drug: DA-3801 Injection

Gonal-F®

ACTIVE COMPARATOR

75 IU/day is injected for 14 days

Drug: Gonal-F®

Interventions

DA-3801 InjectionDRUG
DA-3801 injection
Gonal-F®DRUG
Gonal-F®

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • WHO group II
  • Clomiphene citrate resistance
  • BMI: 17\~29 kg/m\^2
  • Irregular menstrual cycle
  • Normal blood concentration of FSH, E2, prolactin and TSH

You may not qualify if:

  • Uncontrolled endocrine disease
  • Ovarian cystic tumor which are NOT related to PCOS
  • Severe endometriosis
  • Chronic cardiovascular disease, liver complaint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Institutional Review Board

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

InfertilityAnovulation

Interventions

DA-3801follitropin alfa

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 29, 2013

Study Start

January 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

April 15, 2021

Record last verified: 2021-04

Locations

KR(1)