Pharmacokinetics of FSH and hCG After a Single Subcutaneous Injection of Gonadotropins-IBSA

Inclusion criteria

• . Female of childbearing potential, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤45 years of age, with BMI \>18.5 and \<32.0 kg/m2 and body weight ≥45.0 kg.
• . Healthy as defined by:
• . the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• . the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• . Use of a COC containing at least 20 µg of ethinyl estradiol for at least 3 months prior to screening and willing to keep using the same oral contraceptive until the end of the study. The usual regimen (with hormone-free interval or continuous dosing) will be allowed until Day -1. Subjects must agree to take the COC in a continuous manner (no hormone-free interval) from Day 1 to Day 72.
• . Females who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for atleast 3 months prior to dosing) must be willing to use a male condom with intravaginally applied spermicide or total abstinence from heterosexual intercourse (when this is in line with the preferred and usual lifestyle of the subject) from screening and throughout the study and for 30 days after the last study drug administration.
• . Able to understand the study procedures and provide signed informed consent to participate in the study

Exclusion criteria