A Phase 1 interventional study of 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 Infertility, Female, sponsored by Ferring Pharmaceuticals. Completed at 2 sites in China. Open to female participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by Ferring Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 95 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL
Drug: A MENOPUR powder including solvent for solution for injection, 75 IU
Single dose cross-over bioequivalence trial
Also known as: Highly purified menotropin
Single dose cross-over bioequivalence trial
Also known as: Highly purified menotropin
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.
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
Pharmacokinetic parameter of FSH: Cmax
Cmax is defined as baseline adjusted maximum observed concentration.
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: AUCinf
AUCinf is defined as area under concentration-time curve from dosing to infinity using baseline adjusted concentrations.
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
Tmax is defined as time of maximum observed concentration.
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
CL/F is defined as apparent systemic clearance.
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
Vz/F is defined as apparent volume of distribution during terminal phase.
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
λz is defined as first-order rate constant associated with the terminal (log-linear) portion of the concentration-time curve.
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
t½ is defined as terminal half-life.
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
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.
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
AUCinf is defined as area under concentration-time curve from dosing to infinity using baseline adjusted concentrations.
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
Cmax is defined as baseline adjusted maximum observed concentration.
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
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.
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
Cmax is defined as baseline adjusted maximum observed concentration.
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
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).
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
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.
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)
Vital signs comprising systolic and diastolic blood pressure will be presented.
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)
Vital sign comprising pulse will be presented.
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)
Vital sign comprising body temperature will be presented.
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
Change from baseline for 12-lead ECG (heart rate) parameter will be reported.
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
Change from baseline for 12-lead ECG (PR interval) parameter will be reported.
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
Change from baseline for 12-lead ECG (RR interval) parameter will be reported.
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
Change from baseline for 12-lead ECG (QRS interval) parameter will be reported.
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
Change from baseline for 12-lead ECG (QT interval) parameter will be reported.
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
Change from baseline for 12-lead ECG (QTc interval) parameter will be reported.
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
Change from baseline for 12-lead ECG (QRS axis) parameter will be reported.
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
Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, and 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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)
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameters including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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
Blood samples were collected for the analysis of clinical chemistry parameter including: 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)
Change from baseline of haematology parameter: Haematocrit
Blood samples were collected for the analysis of haematology parameter including: Haematocrit.
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 haematology parameter: Haemoglobin
Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.
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 haematology parameter: Mean cellular volume
Blood samples were collected for the analysis of haematology parameter including: Mean cellular volume.
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 haematology parameter: Mean corpuscular haemoglobin content
Blood samples were collected for the analysis of haematology parameter including: Mean corpuscular haemoglobin content.
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 haematology parameter: Mean corpuscular haemoglobin concentration
Blood samples were collected for the analysis of haematology parameter including: Mean corpuscular haemoglobin concentration.
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 haematology parameter: Red blood cell (RBC) count
Blood samples were collected for the analysis of haematology parameter including: RBC count.
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 haematology parameter: Platelet count
Blood samples were collected for the analysis of haematology parameter including: Platelet count.
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 haematology parameter: Reticulocytes
Blood samples were collected for the analysis of haematology parameter including: Reticulocytes.
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 haematology parameter: White blood cell count
Blood samples were collected for the analysis of haematology parameter including: White blood cell count.
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 urinalysis parameter: 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 urinalysis parameter: 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 urinalysis parameter: 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 urinalysis parameter: pH and Specific Gravity
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 urinalysis parameter: Nitrite
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 urinalysis parameter: Ketone
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 urinalysis parameter: Urobilinogen
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 urinalysis parameter: Blood
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 urinalysis parameter: Leukocytes
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)
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Ferring Pharmaceuticals