Infertility, FemalePhase 1NCT04902131
A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women
A Phase 1 study testing A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL and A MENOPUR powder including solvent for solution for injection, 75 IU in people with Infertility, Female, run by Ferring Pharmaceuticals at 2 sites in China.
Trial summary
MENOPUR is a human menotrophin product, with a combination of human follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity. Human chorionic gonadotrophin (hCG) is the major contributor to the LH activity in the product. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL and A MENOPUR powder including solvent for solution for injection, 75 IU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesChina
- Study dates
- 2 Nov 2021to 15 Aug 2022
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese women between the ages of 21 to 40 years at the time of signing the informed consent form
- Non-users or users of the combined oral contraceptive (COC) pill who describe experiencing menstrual cycles of 24 to 35 days in duration (both inclusive)
- Healthy according to medical history, physical and gynecological examinations, vital signs, 12-lead electrocardiogram, and laboratory tests in blood and urine
- Serum FSH levels ≤5 IU/L and estradiol levels ≤50 pg/mL on Day -3 and Day -1 in TP1
Who cannot join
- Any finding at the gynecological examination, transvaginal ultrasound or by cervical smear that is considered medically important
- A history of medical problems that could affect the functioning of the reproductive organs (ovaries and womb)
- A history of any medical problems that may prevent use of the combined hormonal contraceptive pill
Trial locations and contacts
2 sites in 1 country.
China2 sites
Ferring investigational site
Nanjing, Gaoxin District, 210032
Ferring investigational site
Nanjing, 210029
About this study
Official title: An Open-label, Randomised, 2-way Crossover, Single-dose, Bioequivalence Trial Comparing MENOPUR Solution for Injection in Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection, After Subcutaneous Administration in Healthy Women
MENOPUR is a human menotrophin product, with a combination of human follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity. Human chorionic gonadotrophin (hCG) is the major contributor to the LH activity in the product. MENOPUR is approved in more than 130 countries for a variety of strengths and indications. In China, MENOPUR, 75 IU is approved for controlled ovarian hyperstimulation in relation to assisted reproductive technology (ART). The current trial is intended for supporting marketing authorization approval of a new formulation of MENOPUR in China.
MENOPUR is currently available in China as a powder and solvent for solution for injection, containing 75 IU of FSH and 75 IU of LH activity. A new liquid formulation is developed by Ferring Pharmaceuticals for administration with a disposable pre-filled injection pen, containing 600 IU of FSH and 600 IU of LH activity. MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL is the test product and MENOPUR powder and solvent for solution for injection, 75 IU is the reference product in this trial.
- Conditions
- Infertility, Female
- Being tested
- A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL, A MENOPUR powder including solvent for solution for injection, 75 IU
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mLDrug
Also called Highly purified menotropin
Single dose cross-over bioequivalence trial
A MENOPUR powder including solvent for solution for injection, 75 IUDrug
Also called Highly purified menotropin
Single dose cross-over bioequivalence trial
| Study group | Role | What they receive |
|---|---|---|
| MENOPUR pen | Experimental | Not described Receives: Drug: A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL |
| MENOPUR powder | Active comparator | Not described Receives: Drug: A MENOPUR powder including solvent for solution for injection, 75 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of FSH: AUCt
AUCt is defined as area under the concentration-time curve from dosing to the last time point when the baseline adjusted concentration is above zero.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before investigational medicinal product [IMP] administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: Cmax
Cmax is defined as baseline adjusted maximum observed concentration.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Secondary outcomes (58)
Pharmacokinetic parameter of FSH: AUCinf
AUCinf is defined as area under concentration-time curve from dosing to infinity using baseline adjusted concentrations.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: Tmax
Tmax is defined as time of maximum observed concentration.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: CL/F
CL/F is defined as apparent systemic clearance.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: Vz/F
Vz/F is defined as apparent volume of distribution during terminal phase.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: λz
λz is defined as first-order rate constant associated with the terminal (log-linear) portion of the concentration-time curve.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: t½
t½ is defined as terminal half-life.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of human chorionic gonadotrophin (hCG): AUCt
AUCt is defined as area under the concentration-time curve from dosing to the last time point when the baseline adjusted concentration is above zero.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of hCG: AUCinf
AUCinf is defined as area under concentration-time curve from dosing to infinity using baseline adjusted concentrations.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of hCG: Cmax
Cmax is defined as baseline adjusted maximum observed concentration.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of LH: AUCt
AUCt is defined as area under the concentration-time curve from dosing to the last time point when the baseline adjusted concentration is above zero.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and 4, 8, 12, 24 and 48 hours after administration
Pharmacokinetic parameter of LH: Cmax
Cmax is defined as baseline adjusted maximum observed concentration.
Measured: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and 4, 8, 12, 24 and 48 hours after administration
Frequency of adverse events (AEs) stratified by intensity
The frequency of subjects with total AEs and AEs by categories of intensity (mild, moderate, severe) are presented.
An AE was any untoward medical occurrence in a subject participating in clinical trial. The intensity of AE was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activities); moderate = disruption of usual activities (disturbing); or severe = inability to work or perform usual activities (unacceptable).
Measured: From signing of the informed consent up to the end-of-trial (11 to 18 days after the last IMP administration)
Frequency of injection site reactions stratified by intensity
The presence of injection site reactions (redness, pain, itching, swelling and bruising) immediately, 0.5 hours and 24 hours after the injection are presented.
The injection site reactions were assessed as none, mild, moderate and severe. The number of injection site reactions (mild, moderate or severe) based on all assessments performed is presented.
Measured: Immediately after administration, and at 0.5 and 24 hours after administration on Day 1 and Day 2 of Treatment period 1 (TP1) and Time period 2 (TP2)
Change from baseline of vital signs (systolic and diastolic blood pressure)
Vital signs comprising systolic and diastolic blood pressure will be presented.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of vital sign (pulse)
Vital sign comprising pulse will be presented.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of vital sign (body temperature)
Vital sign comprising body temperature will be presented.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead electrocardiogram (ECG): Heart rate
Change from baseline for 12-lead ECG (heart rate) parameter will be reported.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: PR interval
Change from baseline for 12-lead ECG (PR interval) parameter will be reported.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: RR interval
Change from baseline for 12-lead ECG (RR interval) parameter will be reported.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: QRS interval
Change from baseline for 12-lead ECG (QRS interval) parameter will be reported.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: QT interval
Change from baseline for 12-lead ECG (QT interval) parameter will be reported.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: QTc interval
Change from baseline for 12-lead ECG (QTc interval) parameter will be reported.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: QRS axis
Change from baseline for 12-lead ECG (QRS axis) parameter will be reported.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase
Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, and Gamma glutamyl transferase.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Albumin
Blood samples were collected for the analysis of clinical chemistry parameter including: Albumin.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Glucose
Blood samples were collected for the analysis of clinical chemistry parameter including: Glucose.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Calcium
Blood samples were collected for the analysis of clinical chemistry parameter including: Calcium.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Chloride
Blood samples were collected for the analysis of clinical chemistry parameter including: Chloride.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Cholesterol
Blood samples were collected for the analysis of clinical chemistry parameter including: Cholesterol.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Phosphate
Blood samples were collected for the analysis of clinical chemistry parameter including: Phosphate.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Potassium
Blood samples were collected for the analysis of clinical chemistry parameter including: Potassium.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Sodium
Blood samples were collected for the analysis of clinical chemistry parameter including: Sodium.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Urea (blood urea nitrogen)
Blood samples were collected for the analysis of clinical chemistry parameter including: Urea (blood urea nitrogen).
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: C-reactive protein
Blood samples were collected for the analysis of clinical chemistry parameter including: C-reactive protein.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Creatinine, Total bilirubin
Blood samples were collected for the analysis of clinical chemistry parameters including: Creatinine, Total bilirubin.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Thyroid stimulating hormone
Blood samples were collected for the analysis of clinical chemistry parameter including: Thyroid stimulating hormone.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Free triiodothyronine
Blood samples were collected for the analysis of clinical chemistry parameter including: Free triiodothyronine.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Free thyroxine
Blood samples were collected for the analysis of clinical chemistry parameter including: Free thyroxine.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: FSH
Blood samples were collected for the analysis of clinical chemistry parameter including: FSH.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Estradiol
Blood samples were collected for the analysis of clinical chemistry parameter including: Estradiol.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of haematology parameter: Haematocrit
Blood samples were collected for the analysis of haematology parameter including: Haematocrit.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of haematology parameter: Haemoglobin
Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of haematology parameter: Mean cellular volume
Blood samples were collected for the analysis of haematology parameter including: Mean cellular volume.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of haematology parameter: Mean corpuscular haemoglobin content
Blood samples were collected for the analysis of haematology parameter including: Mean corpuscular haemoglobin content.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of haematology parameter: Mean corpuscular haemoglobin concentration
Blood samples were collected for the analysis of haematology parameter including: Mean corpuscular haemoglobin concentration.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of haematology parameter: Red blood cell (RBC) count
Blood samples were collected for the analysis of haematology parameter including: RBC count.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of haematology parameter: Platelet count
Blood samples were collected for the analysis of haematology parameter including: Platelet count.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of haematology parameter: Reticulocytes
Blood samples were collected for the analysis of haematology parameter including: Reticulocytes.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of haematology parameter: White blood cell count
Blood samples were collected for the analysis of haematology parameter including: White blood cell count.
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of urinalysis parameter: Protein
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of urinalysis parameter: Glucose
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of urinalysis parameter: Bilirubin
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of urinalysis parameter: pH and Specific Gravity
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of urinalysis parameter: Nitrite
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of urinalysis parameter: Ketone
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of urinalysis parameter: Urobilinogen
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of urinalysis parameter: Blood
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of urinalysis parameter: Leukocytes
Measured: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start2 Nov 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902131
- Sponsor's protocol ID
- 000347
- Status last verified
- May 2022
- First submitted
- 4 May 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, 2-way Crossover, Single-dose, Bioequivalence Trial Comparing MENOPUR Solution for Injection in Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection, After Subcutaneous Administration in Healthy Women
- ClinicalTrials.gov ID
- NCT04902131
- Acronym / sponsor ID
- 000347
- Conditions
- Infertility, Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 26 May 2021 (actual)
- 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.
MENOPUR is a human menotrophin product, with a combination of human follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity. Human chorionic gonadotrophin (hCG) is the major contributor to the LH activity in the product. MENOPUR is approved in more than 130 countries for a variety of strengths and indications. In China, MENOPUR, 75 IU is approved for controlled ovarian hyperstimulation in relation to assisted reproductive technology (ART). The current trial is intended for supporting marketing authorization approval of a new formulation of MENOPUR in China.
MENOPUR is currently available in China as a powder and solvent for solution for injection, containing 75 IU of FSH and 75 IU of LH activity. A new liquid formulation is developed by Ferring Pharmaceuticals for administration with a disposable pre-filled injection pen, containing 600 IU of FSH and 600 IU of LH activity. MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL is the test product and MENOPUR powder and solvent for solution for injection, 75 IU is the reference product in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MENOPUR pen | Experimental | Drug: A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL |
| MENOPUR powder | Active comparator | Drug: A MENOPUR powder including solvent for solution for injection, 75 IU |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese women between the ages of 21 to 40 years at the time of signing the informed consent form
- Non-users or users of the combined oral contraceptive (COC) pill who describe experiencing menstrual cycles of 24 to 35 days in duration (both inclusive)
- Healthy according to medical history, physical and gynecological examinations, vital signs, 12-lead electrocardiogram, and laboratory tests in blood and urine
- Serum FSH levels ≤5 IU/L and estradiol levels ≤50 pg/mL on Day -3 and Day -1 in TP1
Key exclusion criteria (3 listed)
- Any finding at the gynecological examination, transvaginal ultrasound or by cervical smear that is considered medically important
- A history of medical problems that could affect the functioning of the reproductive organs (ovaries and womb)
- A history of any medical problems that may prevent use of the combined hormonal contraceptive pill
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 |
|---|---|---|
| A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mLAlso: Highly purified menotropinSingle dose cross-over bioequivalence trial | Drug | MENOPUR pen |
| A MENOPUR powder including solvent for solution for injection, 75 IUAlso: Highly purified menotropinSingle dose cross-over bioequivalence trial | Drug | MENOPUR powder |
Primary outcome
Pharmacokinetic parameter of FSH: AUCt
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before investigational medicinal product [IMP] administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
AUCt is defined as area under the concentration-time curve from dosing to the last time point when the baseline adjusted concentration is above zero.
Pharmacokinetic parameter of FSH: Cmax
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Cmax is defined as baseline adjusted maximum observed concentration.
58 secondary outcomes
Pharmacokinetic parameter of FSH: AUCinf
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: Tmax
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: CL/F
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: Vz/F
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: λz
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of FSH: t½
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of human chorionic gonadotrophin (hCG): AUCt
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of hCG: AUCinf
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of hCG: Cmax
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration
Pharmacokinetic parameter of LH: AUCt
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and 4, 8, 12, 24 and 48 hours after administration
Pharmacokinetic parameter of LH: Cmax
Time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and 4, 8, 12, 24 and 48 hours after administration
Frequency of adverse events (AEs) stratified by intensity
Time frame: From signing of the informed consent up to the end-of-trial (11 to 18 days after the last IMP administration)
Frequency of injection site reactions stratified by intensity
Time frame: Immediately after administration, and at 0.5 and 24 hours after administration on Day 1 and Day 2 of Treatment period 1 (TP1) and Time period 2 (TP2)
Change from baseline of vital signs (systolic and diastolic blood pressure)
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of vital sign (pulse)
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of vital sign (body temperature)
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead electrocardiogram (ECG): Heart rate
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: PR interval
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: RR interval
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: QRS interval
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: QT interval
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: QTc interval
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of 12-lead ECG: QRS axis
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Albumin
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Glucose
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Calcium
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Chloride
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Cholesterol
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Phosphate
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Potassium
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Sodium
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Urea (blood urea nitrogen)
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: C-reactive protein
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Creatinine, Total bilirubin
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Thyroid stimulating hormone
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Free triiodothyronine
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Free thyroxine
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: FSH
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
Change from baseline of clinical chemistry: Estradiol
Time frame: On Day -1 in TP1 and TP2, and at the follow-up (end-of-trial, 11 to 18 days after the last IMP administration) visit. Baseline is defined as pre-administration (Day -1)
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 24 Aug 2022.
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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.
Global Clinical Compliance study director
Ferring Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL and A MENOPUR powder including solvent for solution for injection, 75 IU in people with Infertility, Female, run by Ferring Pharmaceuticals at 2 sites in China.
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 4 inclusion and 3 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 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. 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?
Pharmacokinetic parameter of FSH: AUCt (time frame: At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before investigational medicinal product [IMP] administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2022.