Single Dose FSH-GEX™ in Healthy Volunteers
This study has been completed.
Glycotope Biotechnology GmbH
Information provided by:
First received: May 11, 2011
Last updated: November 25, 2011
Last verified: November 2011
The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a single dose administration of four doses of FSH-GEX™ in healthy pituitary-suppressed female volunteers, in comparison with two marketed comparator products.
Drug: Comparator 1
Drug: Comparator 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
||A Phase I, Monocenter, Randomized, Placebo and Comparator Controlled, Single Blind, Rising Dose, Clinical Study to Determine Single Dose Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Four Doses of FSH-GEX™ According to Adaptive Design (25, 75, 150 and 300 IU) Administered Subcutaneously in Healthy Pituitary-suppressed Female Volunteers
Primary Outcome Measures:
- to assess the safety and (local) tolerability of FSH-GEX™ following single rising dose administration by subcutaneous injection [ Designated as safety issue: Yes ]
frequency of dose related adverse events, measurement of vital signs, body measurements, transvaginal ultrasound, ECG and laboratory values in comparison to placebo and the two comparators with marketing authorization
- to determine FSH pharmacokinetic parameters of FSH-GEX™ following single dose administration by subcutaneous injection (part 1) [ Designated as safety issue: No ]
- to determine FSH pharmacokinetic parameters of FSH-GEX™ following single dose administration by subcutaneous injection (part 2) [ Designated as safety issue: No ]
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 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 minmally 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.
- 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 OTC 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 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 hypertensitivity 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 abnomalities.
- 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.
- Injection of one or more doses of any depot contraceptive drug /drug combination or hormonal implants <= 10 months prior to screening.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354886
|Glycotope Investigational Site
|Groningen, Netherlands, 9713 GZ |
Glycotope Biotechnology GmbH
No publications provided
||Glycotope GmbH, Study Director, Glycotope GmbH
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 11, 2011
||November 25, 2011
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Keywords provided by Glycotope GmbH:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 15, 2014
Genital Diseases, Male
Genital Diseases, Female