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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01141270
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : August 4, 2010
Information provided by:
Polymun Scientific GmbH

June 9, 2010
June 10, 2010
August 4, 2010
January 2009
August 2009   (Final data collection date for primary outcome measure)
Area under the serum concentration curve (AUC) of FSH [ Time Frame: 0 -192h after FSH injection ]
Same as current
Complete list of historical versions of study NCT01141270 on Archive Site
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Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application
Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application. A Randomised, Open Label, Cross Over Study

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®).

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Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
  • Drug: AFOLIA
    single sc injection, 225 IU
  • Drug: Gonal-f
    single sc injection, 225IU
  • Experimental: AFOLIA
    225 IU sc
    Intervention: Drug: AFOLIA
  • Active Comparator: Gonal-f
    225 IU sc
    Intervention: Drug: Gonal-f
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2010
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 38 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Brigitta Vcelar PhD, Polymun Scientific GmbH
Polymun Scientific GmbH
Not Provided
Principal Investigator: Michael Wolzt, aoUniv.Prof. Medical University Vienna
Polymun Scientific GmbH
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP