Multiple Dose FSH-GEX(TM) in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01477073
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : January 3, 2013
Glycotope Biotechnology GmbH
Information provided by (Responsible Party):
Glycotope GmbH

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 with two marketed comparator products.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : October 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: 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

Primary Outcome Measures :
  1. safety and tolerability of FSH-GEX™ following multiple dose administration by subcutaneous injection [ Time Frame: 43 days ]
    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 :
  1. pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection [ Time Frame: 28 time points up to 14 days post-dose ]

  2. pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection [ Time Frame: 28 time points up to 14 days post-dose ]

  3. pharmacodynamic parameters of FSH-GEX™ following multiple dose administration by subcutaneous injection [ Time Frame: 17 time points up to 14 days post-dose ]
    Estradiol (E2), Luteinizing Hormone (LH) and inhibin B serum levels

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

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01477073

Glycotope Investigational Site
Groningen, Netherlands, 9713
Sponsors and Collaborators
Glycotope GmbH
Glycotope Biotechnology GmbH
Study Director: Glycotope GmbH Director Glycotope GmbH

Responsible Party: Glycotope GmbH Identifier: NCT01477073     History of Changes
Other Study ID Numbers: GEXGP24102
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: November 2011

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

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