NCT01354886

Brief Summary

The aim of the current study was 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 11, 2011

Last Update Submit

May 10, 2021

Conditions

Female Infertility

Keywords

in-vitro fertilizationreproductive disorder

Outcome Measures

Primary Outcomes (3)

  • to assess the safety and (local) tolerability of FSH-GEX™ following single rising 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

    up to 87 days

  • to determine FSH pharmacokinetic parameters of FSH-GEX™ following single dose administration by subcutaneous injection (part 1)

    Peak plasma concentration (Cmax)

    before FSH/Placebo administration until 240 hours thereafter

  • to determine FSH pharmacokinetic parameters of FSH-GEX™ following single dose administration by subcutaneous injection (part 2)

    Area under the plasma concentration versus time curve (AUC)

    before FSH/Placebo administration until 240 hours thereafter

Secondary Outcomes (2)

  • to assess the pharmacodynamic effect of FSH-GEX™ following single rising dose administration by subcutaneous injection (part 1)

    before FSH/Placebo administration until 240 hours thereafter

  • to assess the pharmacodynamic effect of FSH-GEX™ following single rising dose administration by subcutaneous injection (part 2)

    up to a maximum of 87 days

Study Arms (7)

FSH-GEX 25 IU

EXPERIMENTAL

25 IU single dose

Drug: FSH-GEX™

FSH-GEX 75 IU

EXPERIMENTAL

75 IU single dose

Drug: FSH-GEX™

FSH-GEX 150 IU

EXPERIMENTAL

150 IU single dose

Drug: FSH-GEX™

FSH-GEX 300 IU

EXPERIMENTAL

300 IU single dose

Drug: FSH-GEX™

Gonal-f

ACTIVE COMPARATOR

150 IU single dose

Drug: Gonal-f

Bravelle

ACTIVE COMPARATOR

150 IU single dose

Drug: Bravelle

Placebo

PLACEBO COMPARATOR

single dose

Drug: Placebo

Interventions

FSH-GEX™DRUG

single dose

Also known as: follitropin epsilon
FSH-GEX 150 IUFSH-GEX 25 IUFSH-GEX 300 IUFSH-GEX 75 IU
Gonal-fDRUG

150 IU single dose

Also known as: follitropin alfa
Gonal-f
BravelleDRUG

150 IU single dose

Also known as: urinary FSH
Bravelle
PlaceboDRUG

single dose

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female subjects from 18-40 years of age.
  • Subjects must be in good health.
  • Subjects must be willing to use additional non-hormonal contraception
  • Subjects must have used a combined oral contraceptive (COC) for at least one cycle.
  • 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.
  • Subjects must have a body weight of minimally 50.0 kg with a BMI between 18.0 and 29.0 kg/m\^2 at baseline measurements.
  • 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 10 cigarettes per day.
  • Average daily intake of more than 3 units of alcohol per day or an average weekly intake of more than 21 units alcohol.
  • Use of any prescription drug or ove the counter medication from screening until the end-of-study visit, without prior approval of the investigator.
  • Any drugs thay may reduce the effectiveness of COC from screening until the end-of-study visit.
  • Any follicle-stimulating hormone (FSH) preparation within 90 days prior to screening.
  • 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 blood within 90 days prior to first FSH-GEX™ dosing.
  • History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
  • History of allergies for drugs, seafood, nuts, eggs, wasp-stings; history of atopic allergy (asthma, urticaria, eczematous dermatitis). 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.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycotope Investigational Site

Groningen, 9713 GZ, 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: 28591833RESULT

MeSH Terms

Conditions

Infertility, Female

Interventions

follitropin alfaUrofollitropin

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

MenotropinsGonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Glycotope GmbH

    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

May 11, 2011

First Posted

May 17, 2011

Study Start

April 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations

NL(1)