Status:
COMPLETED
Multiple Dose FSH-GEX(TM) in Healthy Volunteers
Lead Sponsor:
Glycotope GmbH
Collaborating Sponsors:
Glycotope Biotechnology GmbH
Conditions:
Female Infertility
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01477073
Start Date
October 1 2011
End Date
May 1 2012
Last Update
May 7 2021
Active Locations (1)
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1
Glycotope Investigational Site
Groningen, Netherlands, 9713