Female InfertilityPhase 1NCT01354886
Single Dose FSH-GEX™ in Healthy Volunteers
A Phase 1 study testing FSH-GEX™, Gonal-f and Bravelle in people with Female Infertility, run by Glycotope GmbH at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility
- What is being tested?
- FSH-GEX™, Gonal-f and Bravelle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2011to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
- Contraindication for the use of follitropin alfa, 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).
- Porphyria or family history of porphyria.
- History of ovarian surgery.
- Any ovarian or abdominal abnormality that would interfere with adequate ultrasound investigation.
- An abnormal cervical smear.
- 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.
- History of Hepatitis B or C, or a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at the screening visit.
- History of drug or alcohol abuse within the 12 months prior to the screening visit or evidence of such abuse.
- Planned surgery or hospitalization during the period of the study.
- 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.
- Injection of one or more doses of any depot contraceptive drug /drug combination or hormonal implants <= 10 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Monocenter, Randomized, Placebo and Comparator Controlled, Single Blind, Rising Dose, Clinical Study to Determine Single Dose Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Four Doses of FSH-GEX™ According to Adaptive Design (25, 75, 150 and 300 IU) Administered Subcutaneously in Healthy Pituitary-suppressed Female Volunteers
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.
Read the detailed description
Healthy pituitary-suppressed female subjects received FSH-GEX™ (25, 75, 150 and 300 IU) in three of four possible ascending doses or one dose of two comparators (Bravelle® and Gonal-f®) and placebo in random order. The study consisted of three separate treatment periods. During each treatment period the subject received one single dose via a subcutaneous injection in the lower abdominal wall.
- Conditions
- Female Infertility
- Being tested
- FSH-GEX™, Gonal-f, Bravelle, Placebo
- Keywords
- in-vitro fertilization, reproductive disorder
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSH-GEX™Drug
Also called follitropin epsilon
single dose
Gonal-fDrug
Also called follitropin alfa
150 IU single dose
BravelleDrug
Also called urinary FSH
150 IU single dose
PlaceboDrug
single dose
| Study group | Role | What they receive |
|---|---|---|
| FSH-GEX 25 IU | Experimental | 25 IU single dose Receives: Drug: FSH-GEX™ |
| FSH-GEX 75 IU | Experimental | 75 IU single dose Receives: Drug: FSH-GEX™ |
| FSH-GEX 150 IU | Experimental | 150 IU single dose Receives: Drug: FSH-GEX™ |
| FSH-GEX 300 IU | Experimental | 300 IU single dose Receives: Drug: FSH-GEX™ |
| Gonal-f | Active comparator | 150 IU single dose Receives: Drug: Gonal-f |
| Bravelle | Active comparator | 150 IU single dose Receives: Drug: Bravelle |
| Placebo | Placebo comparator | single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
determined by Estradiol (E2) and inhibin B concentrations depending on dose
Measured: 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)
ovarian follicle number and size as determined by transvaginal ultrasonography depending on dose
Measured: up to a maximum of 87 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycotope GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glycotope Biotechnology GmbH
- Responsible party
- Sponsor
- Investigators
- Glycotope GmbH, Study director, Glycotope GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354886
- Sponsor's protocol ID
- GEXGP240101
- Status last verified
- May 2021
- First submitted
- 11 May 2011
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28591833
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Monocenter, Randomized, Placebo and Comparator Controlled, Single Blind, Rising Dose, Clinical Study to Determine Single Dose Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Four Doses of FSH-GEX™ According to Adaptive Design (25, 75, 150 and 300 IU) Administered Subcutaneously in Healthy Pituitary-suppressed Female Volunteers
- ClinicalTrials.gov ID
- NCT01354886
- Acronym / sponsor ID
- GEXGP240101
- Conditions
- Female Infertility
- Keywords
- in-vitro fertilization, reproductive disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Glycotope GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Glycotope Biotechnology GmbH
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Healthy pituitary-suppressed female subjects received FSH-GEX™ (25, 75, 150 and 300 IU) in three of four possible ascending doses or one dose of two comparators (Bravelle® and Gonal-f®) and placebo in random order. The study consisted of three separate treatment periods. During each treatment period the subject received one single dose via a subcutaneous injection in the lower abdominal wall.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| FSH-GEX 25 IU | Experimental | Drug: FSH-GEX™25 IU single dose |
| FSH-GEX 75 IU | Experimental | Drug: FSH-GEX™75 IU single dose |
| FSH-GEX 150 IU | Experimental | Drug: FSH-GEX™150 IU single dose |
| FSH-GEX 300 IU | Experimental | Drug: FSH-GEX™300 IU single dose |
| Gonal-f | Active comparator | Drug: Gonal-f150 IU single dose |
| Bravelle | Active comparator | Drug: Bravelle150 IU single dose |
| Placebo | Placebo comparator | Drug: Placebosingle dose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FSH-GEX™Also: follitropin epsilonsingle dose | Drug | FSH-GEX 150 IU, FSH-GEX 25 IU, FSH-GEX 300 IU, FSH-GEX 75 IU |
| Gonal-fAlso: follitropin alfa150 IU single dose | Drug | Gonal-f |
| BravelleAlso: urinary FSH150 IU single dose | Drug | Bravelle |
| Placebosingle dose | Drug | Placebo |
Primary outcome
to assess the safety and (local) tolerability of FSH-GEX™ following single rising dose administration by subcutaneous injection
Time frame: up to 87 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
to determine FSH pharmacokinetic parameters of FSH-GEX™ following single dose administration by subcutaneous injection (part 1)
Time frame: before FSH/Placebo administration until 240 hours thereafter
Peak plasma concentration (Cmax)
to determine FSH pharmacokinetic parameters of FSH-GEX™ following single dose administration by subcutaneous injection (part 2)
Time frame: before FSH/Placebo administration until 240 hours thereafter
Area under the plasma concentration versus time curve (AUC)
2 secondary outcomes
to assess the pharmacodynamic effect of FSH-GEX™ following single rising dose administration by subcutaneous injection (part 1)
Time frame: 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)
Time frame: up to a maximum of 87 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Results publication: PubMed 28591833Abd-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glycotope GmbH study director
Glycotope GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FSH-GEX™, Gonal-f and Bravelle in people with Female Infertility, run by Glycotope GmbH at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the safety and (local) tolerability of FSH-GEX™ following single rising dose administration by subcutaneous injection (time frame: up to 87 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.