Single Dose FSH-GEX™ in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Glycotope Biotechnology GmbH
Information provided by:
Glycotope GmbH
ClinicalTrials.gov Identifier:
NCT01354886
First received: May 11, 2011
Last updated: November 25, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Female Infertility
Drug: FSH-GEX™
Drug: Comparator 1
Drug: Comparator 2
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Glycotope GmbH:

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 ]
    C(max)

  • to determine FSH pharmacokinetic parameters of FSH-GEX™ following single dose administration by subcutaneous injection (part 2) [ Designated as safety issue: No ]
    AUC(0-last)


Secondary Outcome Measures:
  • to assess the pharmacodynamic effect of FSH-GEX™ following single rising dose administration by subcutaneous injection (part 1) [ Designated as safety issue: No ]
    determined by Estradiol (E2) and inhibin B concentrations depending on dose

  • to assess the pharmacodynamic effect of FSH-GEX™ following single rising dose administration by subcutaneous injection (part 2) [ Designated as safety issue: Yes ]
    ovarian follicle number and size as determined by transvaginal ultrasonography depending on dose


Estimated Enrollment: 18
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female subjects from 18-40 years of age.
  2. Subjects must be in good health.
  3. Subjects must be willing to use additional non-hormonal contraception
  4. Subjects must have used a COC for at least one cycle.
  5. 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.
  6. 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.
  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 10 cigarettes per day.
  2. Average daily intake of more than 3 units of alcohol per day or an average weekly intake of more than 21 units alcohol.
  3. Use of any prescription drug or OTC medication from screening until the end-of-study visit, without prior approval of the investigator.
  4. Any drugs thay may reduce the effectiveness of COC from screening until the end-of-study visit.
  5. Any FSH preparation within 90 days prior to screening.
  6. Administration of any investigational product or use of any investigational device within 30 days prior to screening.
  7. Donation or loss of 500 mL or more blood within 90 days prior to first FSH-GEX™ dosing.
  8. History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
  9. 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.
  10. 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.
  11. History or presence of any malignancy.
  12. Determined or suspected pregnancy.
  13. Breast feeding women.
  14. History of (or current) endocrine abnomalities.
  15. Contraindication for the use of oral contraceptives.
  16. 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).
  17. Porphyria or family history of porphyria.
  18. History of ovarian surgery.
  19. Any ovarian or abdominal abnormality that would interfere with adequate ultrasound investigation.
  20. An abnormal cervical smear.
  21. 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.
  22. History of Hepatitis B or C, or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at the screening visit.
  23. History of drug or alcohol abuse within the 12 months prior to the screening visit or evidence of such abuse.
  24. Planned surgery or hospitalization during the period of the study.
  25. 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.
  26. Injection of one or more doses of any depot contraceptive drug /drug combination or hormonal implants <= 10 months prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354886

Locations
Netherlands
Glycotope Investigational Site
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Glycotope GmbH
Glycotope Biotechnology GmbH
Investigators
Study Director: Glycotope GmbH Glycotope GmbH
  More Information

No publications provided

Responsible Party: Glycotope GmbH, Study Director, Glycotope GmbH
ClinicalTrials.gov Identifier: NCT01354886     History of Changes
Other Study ID Numbers: GEXGP240101
Study First Received: May 11, 2011
Last Updated: November 25, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Glycotope GmbH:
in-vitro fertilization
reproductive disorder

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 21, 2014