Multiple Dose FSH-GEX(TM) in Healthy Volunteers

NCT ID: NCT01477073

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-05-31

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 or placebo.

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)) for maximal 7 Days. They were compared with subjects who received a urinary FSH or a recombinant FSH or placebo.

Conditions

Female Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FSH-GEX 75 IU

follitropin epsilon 75 IU QD

Group Type: EXPERIMENTAL

FSH-GEX™

Intervention Type: DRUG

FSH-GEX 150 IU

follitropin epsilon 150 IU QD

Group Type: EXPERIMENTAL

FSH-GEX™

Intervention Type: DRUG

FSH-GEX 150 IU QAD

follitropin epsilon 150 IU QAD

Group Type: EXPERIMENTAL

FSH-GEX™

Intervention Type: DRUG

recombinant FSH

Gonal-f 150 IU QD

Group Type: ACTIVE_COMPARATOR

recombinant FSH

Intervention Type: DRUG

urinary FSH

Bravelle 150 IU QD

Group Type: ACTIVE_COMPARATOR

urinary FSH

Intervention Type: DRUG

Placebo

Placebo QD

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

FSH-GEX™

Intervention Type: DRUG

recombinant FSH

Intervention Type: DRUG

urinary FSH

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

follitropin epsilon; Gonal-f; Bravelle

Eligibility 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 over-the-counter 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 combination oral contraceptive (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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Glycotope Biotechnology GmbH

INDUSTRY

Sponsor Role: collaborator

Glycotope GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glycotope GmbH Director

Role: STUDY_DIRECTOR

Glycotope GmbH

Locations

Glycotope Investigational Site

Groningen, , Netherlands

Countries

Netherlands

References

Abd-Elaziz K, Duijkers I, Stockl L, Dietrich B, Klipping C, Eckert K, Goletz S. A new fully human recombinant FSH (follitropin epsilon): two phase I randomized placebo and comparator-controlled pharmacokinetic and pharmacodynamic trials. Hum Reprod. 2017 Aug 1;32(8):1639-1647. doi: 10.1093/humrep/dex220.

Reference Type: RESULT

PMID: 28591833 (View on PubMed)

Other Identifiers

GEXGP24102

Identifier Type: -

Identifier Source: org_study_id