Female InfertilityPhase 1NCT01477073
Multiple Dose FSH-GEX(TM) in Healthy Volunteers
A Phase 1 study testing FSH-GEX™, recombinant FSH and urinary FSH in people with Female Infertility, run by Glycotope GmbH at 1 site in Netherlands.
Trial 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. 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™, recombinant FSH and urinary FSH
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to May 2012
- 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 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.
Who cannot join
- 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).
Show all 25Show fewer
- 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).
- 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 or previous participation in the 104676-CS0160 (FSH-GEXTM) study.
- Injection of one or more doses of any depot contraceptive drug /drug combination ≤10 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- FSH-GEX™, recombinant FSH, urinary FSH, 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
recombinant FSHDrug
Also called Gonal-f
urinary FSHDrug
Also called Bravelle
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| FSH-GEX 75 IU | Experimental | follitropin epsilon 75 IU QD Receives: Drug: FSH-GEX™ |
| FSH-GEX 150 IU | Experimental | follitropin epsilon 150 IU QD Receives: Drug: FSH-GEX™ |
| FSH-GEX 150 IU QAD | Experimental | follitropin epsilon 150 IU QAD Receives: Drug: FSH-GEX™ |
| recombinant FSH | Active comparator | Gonal-f 150 IU QD Receives: Drug: recombinant FSH |
| urinary FSH | Active comparator | Bravelle 150 IU QD Receives: Drug: urinary FSH |
| Placebo | Placebo comparator | Placebo QD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 43 days
Secondary outcomes (4)
pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection (part 1)
Peak Plasma Concentration (Cmax)
Measured: 28 time points up to 14 days post-dose
pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection (part 2)
Area under the plasma concentration versus time curve (AUC)
Measured: 28 time points up to 14 days post-dose
pharmacodynamic parameters of FSH-GEX™ following multiple dose administration by subcutaneous injection
Estradiol (E2), Luteinizing Hormone (LH) and inhibin B serum levels
Measured: 17 time points up to 14 days post-dose
pharmacodynamic parameters of FSH-GEX™ following multiple dose administration by subcutaneous injection
follicular response and endometrial thickness as determined by transvaginal ultrasonography
Measured: 9 time points up to14 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionMay 2012
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
- 57 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 Director, Study director, Glycotope GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477073
- Sponsor's protocol ID
- GEXGP24102
- Status last verified
- May 2021
- First submitted
- 9 Nov 2011
- Last updated
- 7 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 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01477073
- Acronym / sponsor ID
- GEXGP24102
- Conditions
- Female Infertility
- Keywords
- in-vitro fertilization, reproductive disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Glycotope GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Glycotope Biotechnology GmbH
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Nov 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| FSH-GEX 75 IU | Experimental | Drug: FSH-GEX™follitropin epsilon 75 IU QD |
| FSH-GEX 150 IU | Experimental | Drug: FSH-GEX™follitropin epsilon 150 IU QD |
| FSH-GEX 150 IU QAD | Experimental | Drug: FSH-GEX™follitropin epsilon 150 IU QAD |
| recombinant FSH | Active comparator | Drug: recombinant FSHGonal-f 150 IU QD |
| urinary FSH | Active comparator | Drug: urinary FSHBravelle 150 IU QD |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo QD |
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 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
Key exclusion criteria (25 listed)
- 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.
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 epsilon | Drug | FSH-GEX 150 IU, FSH-GEX 150 IU QAD, FSH-GEX 75 IU |
| recombinant FSHAlso: Gonal-f | Drug | recombinant FSH |
| urinary FSHAlso: Bravelle | Drug | urinary FSH |
| Placebo | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection (part 1)
Time frame: 28 time points up to 14 days post-dose
pharmacokinetic profile of FSH-GEX™ following multiple dose administration by subcutaneous injection (part 2)
Time frame: 28 time points up to 14 days post-dose
pharmacodynamic parameters of FSH-GEX™ following multiple dose administration by subcutaneous injection
Time frame: 17 time points up to 14 days post-dose
pharmacodynamic parameters of FSH-GEX™ following multiple dose administration by subcutaneous injection
Time frame: 9 time points up to14 days post-dose
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 7 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 Director 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™, recombinant FSH and urinary FSH 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 25 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 7 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?
safety and tolerability of FSH-GEX™ following multiple dose administration by subcutaneous injection (time frame: 43 days). 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 NCT01477073, 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 7 May 2021.