Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application

This study has been completed.
Sponsor:
Information provided by:
Polymun Scientific GmbH
ClinicalTrials.gov Identifier:
NCT01141270
First received: June 9, 2010
Last updated: August 3, 2010
Last verified: August 2010
  Purpose

Comparative pharmacokinetics study after single subcutaneous application of AFOLIA and the reference product (Gonal-f®).

Objective: To demonstrate equivalence within the 80%-125% margin of the reference product for the area under the curve (AUC) of AFOLIA compared to (Gonal-f®).


Condition Intervention Phase
Healthy
Drug: AFOLIA
Drug: Gonal-f
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application. A Randomised, Open Label, Cross Over Study

Further study details as provided by Polymun Scientific GmbH:

Primary Outcome Measures:
  • Area under the serum concentration curve (AUC) of FSH [ Time Frame: 0 -192h after FSH injection ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFOLIA
225 IU sc
Drug: AFOLIA
single sc injection, 225 IU
Active Comparator: Gonal-f
225 IU sc
Drug: Gonal-f
single sc injection, 225IU

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female volunteers
  • Age between 18-38 years
  • Body mass index 17-29 kg/m2
  • Woman of child bearing potential must agree to practice effective barrier methods for birth control
  • Use of oral contraceptives for at least 3 months before study entry
  • Regular menstruation cycle (25-34 days) before initiation of oral contraception
  • Presence of both ovaries
  • Normal findings in medical history and physical and gynaecological examination unless the investigator considers an abnormality to be clinically irrelevant for this study
  • Signed informed consent

Exclusion Criteria:

  • Polycystic ovary syndrome (PCOS)
  • History of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome, OHSS)
  • Impaired thyroid function (treated or untreated)
  • History of malignant disease
  • AST and/or ALAT > 2 x ULN
  • Other clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
  • Smoking habits of more than 5 cigarettes per day
  • Abuse of alcoholic beverages and drugs
  • Participation in a clinical trial within 3 weeks prior to the study
  • Foreseen inability to attend to scheduled study visits
  • Symptoms of a clinically relevant illness during 3 weeks prior the first study day
  • Pregnancy or lactation period
  • Any medical condition that, in the opinion of the investigator, would interfere with safety of the subject or interference of the objectives of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141270

Sponsors and Collaborators
Polymun Scientific GmbH
Investigators
Principal Investigator: Michael Wolzt, aoUniv.Prof. Medical University Vienna
  More Information

No publications provided

Responsible Party: Brigitta Vcelar PhD, Polymun Scientific GmbH
ClinicalTrials.gov Identifier: NCT01141270     History of Changes
Other Study ID Numbers: FIN1001
Study First Received: June 9, 2010
Last Updated: August 3, 2010
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Polymun Scientific GmbH:
recombinant human follicle stimulating hormone
pharmacokinetics
bioequivalence

ClinicalTrials.gov processed this record on November 24, 2014