Multiple Dose FSH-GEX(TM) in Healthy Volunteers

Healthy pituitary-suppressed female subjects received multiple doses of FSH-GEX at one of 2 different dose levels (75 IU and 150 IU dosing once daily (QD), or 150 IU (dosing once every other day (QAD)) for maximal 7 Days. They were compared with subjects who received a urinary FSH or a recombinant FSH or placebo.

Inclusion criteria

• Female subjects from 18-40 years of age at screening.
• Subjects must be in good health as determined by medical and gynecological history, physical and gynecological examination, vital signs, body measurements, electrocardiogram, and laboratory tests
• Subjects must be willing to use additional non-hormonal contraception
• Subjects must have used a combined oral contraceptive, combined contraceptive vaginal ring or combined contraceptive patch
• Vital signs which are within the following ranges: systolic blood pressure between 90-140 mmHg, diastolic blood pressure between 50-90 mmHg, pulse rate between 40 - 100 bpm
• Subjects must have a body weight of minimally 50.0 kg with a BMI between 18.0 and 29.9 kg/m2
• 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 5 cigarettes per day.
• Average daily intake of more than 3 units of alcohol per day (where 1 unit equals 250 mL of beer, 125 mL of wine or 25 mL of spirits) or an average weekly intake of more than 21 units alcohol.
• Use of any prescription drug or over-the-counter medication from screening until the end-of-study visit, without prior approval of the investigator. Paracetamol® is acceptable without prior approval.
• Any drugs that may reduce the effectiveness of combination oral contraceptive (COC) from screening until the end-of-study visit
• 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 of blood within 90 days prior to first dosing of FSH-GEX(TM).
• History of acute or chronic bronchospastic disease
• History of allergies for drugs, seafood, nuts, eggs, wasp-stings; history of atopic allergy. 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, follicle-stimulating hormone (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 or previous participation in the 104676-CS0160 (FSH-GEXTM) study.
• Injection of one or more doses of any depot contraceptive drug /drug combination ≤10 months prior to screening.