Overview

Multiple Dose FSH-GEX(TM) in Healthy Volunteers

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
Female
Summary
The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a multiple dose administration of FSH-GEX™ in healthy pituitary-suppressed female volunteers, in comparison with two marketed comparator products or placebo.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Glycotope GmbH
Collaborator:
Glycotope Biotechnology GmbH
Treatments:
Follicle Stimulating Hormone
Criteria
Inclusion Criteria:

1. Female subjects from 18-40 years of age at screening.

2. 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

3. Subjects must be willing to use additional non-hormonal contraception

4. Subjects must have used a combined oral contraceptive, combined contraceptive vaginal
ring or combined contraceptive patch

5. 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

6. Subjects must have a body weight of minimally 50.0 kg with a BMI between 18.0 and 29.9
kg/m2

7. Able to provide written informed consent prior to study participation.

8. Able to communicate well with the investigator and to understand and comply with the
requirements of the study.

Exclusion Criteria:

1. Smokers of more than 5 cigarettes per day.

2. 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.

3. 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.

4. Any drugs that may reduce the effectiveness of combination oral contraceptive (COC)
from screening until the end-of-study visit

5. Administration of any investigational product or use of any investigational device
within 30 days prior to Screening.

6. Donation or loss of 500 mL or more of blood within 90 days prior to first dosing of
FSH-GEX(TM).

7. History of acute or chronic bronchospastic disease

8. History of allergies for drugs, seafood, nuts, eggs, wasp-stings; history of atopic
allergy. A known hypersensitivity to any of the study drugs.

9. 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.

10. History or presence of any malignancy.

11. Determined or suspected pregnancy.

12. Breast feeding women.

13. History of (or current) endocrine abnormalities

14. Contraindication for the use of oral contraceptives

15. 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).

16. Porphyria or family history of porphyria.

17. History of ovarian surgery.

18. Any ovarian or abdominal abnormality that would interfere with adequate ultrasound
investigation.

19. An abnormal cervical smear

20. 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.

21. History of Hepatitis B or C, or a positive Hepatitis B surface antigen (HBsAg) or
Hepatitis C test result at the screening visit.

22. History of drug or alcohol abuse within the 12 months prior to the screening visit or
evidence of such abuse

23. Planned surgery or hospitalization during the period of the study.

24. 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.

25. Injection of one or more doses of any depot contraceptive drug /drug combination ≤10
months prior to screening.