Single Dose FSH-GEX™ in Healthy Volunteers

Healthy pituitary-suppressed female subjects received FSH-GEX™ (25, 75, 150 and 300 IU) in three of four possible ascending doses or one dose of two comparators (Bravelle® and Gonal-f®) and placebo in random order. The study consisted of three separate treatment periods. During each treatment period the subject received one single dose via a subcutaneous injection in the lower abdominal wall.

Inclusion criteria

• Female subjects from 18-40 years of age.
• Subjects must be in good health.
• Subjects must be willing to use additional non-hormonal contraception
• Subjects must have used a combined oral contraceptive (COC) for at least one cycle.
• Vital signs which are within the following ranges at baseline measurements: systolic blood pressure of 90-140 mmHg, diastolic blood pressure of 50-90 mmHg and pulse rate of 40 - 100 bpm.
• Subjects must have a body weight of minimally 50.0 kg with a BMI between 18.0 and 29.0 kg/m^2 at baseline measurements.
• Able to provide written informed consent prior to study participation.
• Able to communicate well with the investigator and to understand and comply with the requirements of the study.

Exclusion criteria

• Smokers of more than 10 cigarettes per day.
• Average daily intake of more than 3 units of alcohol per day or an average weekly intake of more than 21 units alcohol.
• Use of any prescription drug or ove the counter medication from screening until the end-of-study visit, without prior approval of the investigator.
• Any drugs thay may reduce the effectiveness of COC from screening until the end-of-study visit.
• Any follicle-stimulating hormone (FSH) preparation within 90 days prior to screening.
• Administration of any investigational product or use of any investigational device within 30 days prior to screening.
• Donation or loss of 500 mL or more blood within 90 days prior to first FSH-GEX™ dosing.
• History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
• History of allergies for drugs, seafood, nuts, eggs, wasp-stings; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to any of the study drugs.
• Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of drugs or which may jeopardize the subject in case of participation in the study.
• History or presence of any malignancy.
• Determined or suspected pregnancy.
• Breast feeding women.
• History of (or current) endocrine abnormalities.
• Contraindication for the use of oral contraceptives.
• Contraindication for the use of follitropin alfa, FSH or any of the excipients (hypersensitivity to follitropin alfa, FSH or any of the excipients; tumors of the hypothalamus or the pituitary gland; ovarian enlargement or cyst not due to polycystic ovarian disease; gynecological bleeding of unknown origin; ovarian, uterine, or mammary carcinoma).
• Porphyria or family history of porphyria.
• History of ovarian surgery.
• Any ovarian or abdominal abnormality that would interfere with adequate ultrasound investigation.
• An abnormal cervical smear.
• History or presence of an immune-compromising disease, or a positive human immunodeficiency virus (HIV) test result in the past or at the screening visit.
• History of Hepatitis B or C, or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at the screening visit.
• History of drug or alcohol abuse within the 12 months prior to the screening visit or evidence of such abuse.
• Planned surgery or hospitalization during the period of the study.
• Concurrent participation or participation within 30 days before screening in another clinical trial, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study.
• Injection of one or more doses of any depot contraceptive drug /drug combination or hormonal implants <= 10 months prior to screening.