Multiple Dose FSH-GEX(TM) in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Glycotope Biotechnology GmbH
Information provided by (Responsible Party):
Glycotope GmbH
ClinicalTrials.gov Identifier:
NCT01477073
First received: November 9, 2011
Last updated: January 2, 2013
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Female Infertility
Drug: FSH-GEX™
Drug: Drug: Comparator 1
Drug: Drug: Comparator 2
Drug: Drug: Placebo
Drug: FSH-GEX
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, Mono-center, Placebo and Comparator Controlled, Single-blind, Randomized, Parallel Group, Clinical Study to Determine Multiple Dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FSH-GEX(TM) Administered Subcutaneously in Healthy Pituitary-suppressed Female Volunteers

Resource links provided by NLM:


Further study details as provided by Glycotope GmbH:

Primary Outcome Measures:
  • safety and tolerability of FSH-GEX™ following multiple dose administration by subcutaneous injection [ Time Frame: 43 days ] [ 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


Secondary Outcome Measures:
  • pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection [ Time Frame: 28 time points up to 14 days post-dose ] [ Designated as safety issue: No ]
    C(max)

  • pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection [ Time Frame: 28 time points up to 14 days post-dose ] [ Designated as safety issue: No ]
    AUC(0-last)

  • pharmacodynamic parameters of FSH-GEX™ following multiple dose administration by subcutaneous injection [ Time Frame: 17 time points up to 14 days post-dose ] [ Designated as safety issue: No ]
    Estradiol (E2), Luteinizing Hormone (LH) and inhibin B serum levels

  • pharmacodynamic parameters of FSH-GEX™ following multiple dose administration by subcutaneous injection [ Time Frame: 9 time points up to14 days post-dose ] [ Designated as safety issue: Yes ]
    follicular response and endometrial thickness as determined by transvaginal ultrasonography


Enrollment: 57
Study Start Date: October 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FSH-GEX Drug: FSH-GEX™ Drug: FSH-GEX
Active Comparator: recombinant FSH
recombinant FSH
Drug: Drug: Comparator 1
Active Comparator: urinary FSH
urinary FSH
Drug: Drug: Comparator 2
Placebo Comparator: Placebo Drug: Drug: Placebo Drug: Placebo

  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 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 OTC 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 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.
  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: NCT01477073

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

No publications provided

Responsible Party: Glycotope GmbH
ClinicalTrials.gov Identifier: NCT01477073     History of Changes
Other Study ID Numbers: GEXGP24102
Study First Received: November 9, 2011
Last Updated: January 2, 2013
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 September 16, 2014