Multiple Dose FSH-GEX(TM) in Healthy Volunteers

NCT01477073 | Completed Phase 1

• 1 other identifier: GEXGP24102
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility

Keywords

in-vitro fertilization; reproductive disorder

Outcome Measures

Primary Outcomes (1)

• safety and tolerability of FSH-GEX™ following multiple dose administration by subcutaneous injection

  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

  43 days

Secondary Outcomes (4)

• pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection (part 1)

  28 time points up to 14 days post-dose

• pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection (part 2)

  28 time points up to 14 days post-dose

• pharmacodynamic parameters of FSH-GEX™ following multiple dose administration by subcutaneous injection

  17 time points up to 14 days post-dose

• pharmacodynamic parameters of FSH-GEX™ following multiple dose administration by subcutaneous injection

  9 time points up to14 days post-dose

Study Arms (6)

FSH-GEX 75 IU

EXPERIMENTAL

follitropin epsilon 75 IU QD

Drug: FSH-GEX™

FSH-GEX 150 IU

EXPERIMENTAL

follitropin epsilon 150 IU QD

Drug: FSH-GEX™

FSH-GEX 150 IU QAD

EXPERIMENTAL

follitropin epsilon 150 IU QAD

Drug: FSH-GEX™

recombinant FSH

ACTIVE COMPARATOR

Gonal-f 150 IU QD

Drug: recombinant FSH

urinary FSH

ACTIVE COMPARATOR

Bravelle 150 IU QD

Drug: urinary FSH

Placebo

PLACEBO COMPARATOR

Placebo QD

Drug: Placebo

Interventions

FSH-GEX™ DRUG

Also known as: follitropin epsilon

FSH-GEX 150 IU; FSH-GEX 150 IU QAD; FSH-GEX 75 IU

recombinant FSH DRUG

Also known as: Gonal-f

recombinant FSH

urinary FSH DRUG

Also known as: Bravelle

urinary FSH

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects from 18-40 years of age at screening.
• 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
• Subjects must be willing to use additional non-hormonal contraception
• Subjects must have used a combined oral contraceptive, combined contraceptive vaginal ring or combined contraceptive patch
• 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
• Subjects must have a body weight of minimally 50.0 kg with a BMI between 18.0 and 29.9 kg/m2
• 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.

You may not qualify if:

• Smokers of more than 5 cigarettes per day.
• 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.
• 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.
• Any drugs that may reduce the effectiveness of combination oral contraceptive (COC) from screening until the end-of-study visit
• 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 of blood within 90 days prior to first dosing of FSH-GEX(TM).
• History of acute or chronic bronchospastic disease
• History of allergies for drugs, seafood, nuts, eggs, wasp-stings; history of atopic allergy. A known hypersensitivity 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 abnormalities
• 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).

Sponsors & Collaborators

• Glycotope GmbH: lead
• Glycotope Biotechnology GmbH: collaborator

Study Sites (1)

Glycotope Investigational Site

Groningen, 9713, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 28591833 RESULT

MeSH Terms

Conditions

Infertility, Female

Interventions

follitropin alfa; Urofollitropin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Menotropins; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Glycotope GmbH Director

  Glycotope GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 22, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

NL (1)