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

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

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
Intervention Model: Crossover Assignment
Masking: None (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 ]

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
single sc injection, 225 IU
Active Comparator: Gonal-f
225 IU sc
Drug: Gonal-f
single sc injection, 225IU


Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01141270

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

Responsible Party: Brigitta Vcelar PhD, Polymun Scientific GmbH Identifier: NCT01141270     History of Changes
Other Study ID Numbers: FIN1001
Study First Received: June 9, 2010
Last Updated: August 3, 2010

Keywords provided by Polymun Scientific GmbH:
recombinant human follicle stimulating hormone
bioequivalence processed this record on August 18, 2017