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Completed

NCT Number: NCT04902131

A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation 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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Ferring investigational site, Nanjing, Gaoxin District, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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:

  • 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

Treatment and study plan

A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL

Drug

Single dose cross-over bioequivalence trial

Other names: Highly purified menotropin

A MENOPUR powder including solvent for solution for injection, 75 IU

Drug

Single dose cross-over bioequivalence trial

Other names: Highly purified menotropin

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    AUCinf is defined as area under concentration-time curve from dosing to infinity using baseline adjusted concentrations.

  2. 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

    Tmax is defined as time of maximum observed concentration.

  3. 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

    CL/F is defined as apparent systemic clearance.

  4. 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

    Vz/F is defined as apparent volume of distribution during terminal phase.

  5. 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

    λz is defined as first-order rate constant associated with the terminal (log-linear) portion of the concentration-time curve.

  6. 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

    t½ is defined as terminal half-life.

  7. 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

    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.

  8. 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

    AUCinf is defined as area under concentration-time curve from dosing to infinity using baseline adjusted concentrations.

  9. 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

    Cmax is defined as baseline adjusted maximum observed concentration.

  10. 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

    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.

  11. 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

    Cmax is defined as baseline adjusted maximum observed concentration.

  12. 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)

    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).

  13. 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)

    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.

  14. 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)

    Vital signs comprising systolic and diastolic blood pressure will be presented.

  15. 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)

    Vital sign comprising pulse will be presented.

  16. 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)

    Vital sign comprising body temperature will be presented.

  17. 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 for 12-lead ECG (heart rate) parameter will be reported.

  18. 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 for 12-lead ECG (PR interval) parameter will be reported.

  19. 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 for 12-lead ECG (RR interval) parameter will be reported.

  20. 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 for 12-lead ECG (QRS interval) parameter will be reported.

  21. 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 for 12-lead ECG (QT interval) parameter will be reported.

  22. 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 for 12-lead ECG (QTc interval) parameter will be reported.

  23. 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 for 12-lead ECG (QRS axis) parameter will be reported.

  24. 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)

    Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, and Gamma glutamyl transferase.

  25. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Albumin.

  26. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Glucose.

  27. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Calcium.

  28. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Chloride.

  29. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Cholesterol.

  30. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Phosphate.

  31. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Potassium.

  32. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Sodium.

  33. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Urea (blood urea nitrogen).

  34. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: C-reactive protein.

  35. 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)

    Blood samples were collected for the analysis of clinical chemistry parameters including: Creatinine, Total bilirubin.

  36. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Thyroid stimulating hormone.

  37. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Free triiodothyronine.

  38. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Free thyroxine.

  39. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: FSH.

  40. 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)

    Blood samples were collected for the analysis of clinical chemistry parameter including: Estradiol.

  41. Change from baseline of haematology parameter: 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)

    Blood samples were collected for the analysis of haematology parameter including: Haematocrit.

  42. Change from baseline of haematology parameter: 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)

    Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.

  43. Change from baseline of haematology parameter: 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)

    Blood samples were collected for the analysis of haematology parameter including: Mean cellular volume.

  44. Change from baseline of haematology parameter: 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)

    Blood samples were collected for the analysis of haematology parameter including: Mean corpuscular haemoglobin content.

  45. Change from baseline of haematology parameter: 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)

    Blood samples were collected for the analysis of haematology parameter including: Mean corpuscular haemoglobin concentration.

  46. Change from baseline of haematology parameter: Red blood cell (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)

    Blood samples were collected for the analysis of haematology parameter including: RBC count.

  47. Change from baseline of haematology parameter: 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)

    Blood samples were collected for the analysis of haematology parameter including: Platelet count.

  48. Change from baseline of haematology parameter: 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)

    Blood samples were collected for the analysis of haematology parameter including: Reticulocytes.

  49. Change from baseline of haematology parameter: 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)

    Blood samples were collected for the analysis of haematology parameter including: White blood cell count.

  50. 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)

  51. 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)

  52. 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)

  53. 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)

  54. 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)

  55. 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)

  56. 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)

  57. 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)

  58. 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)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 26, 2021
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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