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

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Drug: AFOLIA Drug: Gonal-f Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: AFOLIA
225 IU sc
single sc injection, 225 IU
Active Comparator: Gonal-f
225 IU sc
Drug: Gonal-f
single sc injection, 225IU

Primary Outcome Measures :
  1. Area under the serum concentration curve (AUC) of FSH [ Time Frame: 0 -192h after FSH injection ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01141270

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

Responsible Party: Brigitta Vcelar PhD, Polymun Scientific GmbH Identifier: NCT01141270     History of Changes
Other Study ID Numbers: FIN1001
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: August 4, 2010
Last Verified: August 2010

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