Status:
COMPLETED
Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application
Lead Sponsor:
Polymun Scientific GmbH
Conditions:
Healthy
Eligibility:
FEMALE
18-38 years
Phase:
PHASE1
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 refere...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01141270
Start Date
January 1 2009
End Date
July 1 2010
Last Update
August 4 2010
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