Infertility
Conditions
Keywords
In vitro fertilisation, Controlled ovarian stimulation
Brief summary
FE 999049 is a gonadotropin preparation containing recombinant human follicle stimulating hormone (rhFSH) under development by Ferring Pharmaceuticals. It is intended for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. In previous trials the exposure to and dose proportionality of FE 999049 in a clinically relevant dose range in Caucasian and Japanese healthy women have been shown to be very similar. This is a trial in healthy Chinese women investigating the pharmacokinetics, safety, and tolerability of a single subcutaneous dose of FE 999049.
Interventions
Solution for Injection, subcutaneous administration
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Female of Chinese origin, with two ethnic Chinese parents and four ethnic Chinese grandparents 21-40 years of age (both inclusive) * Willing to stop using combined oral contraceptives (COC) in relation to the first DECAPEPTYL Depot administration on Day -28 * Agrees to use a double barrier method of contraception between Day -63 and Day 28, if not abstinent. A double barrier method of contraception should also be used after Day 28 until menses resumes or until another contraceptive method has been established * Normal menstrual cycles with a range of 24-35 days in the absence of oral contraceptives * Serum FSH less than equal to (≤)5 IU/L on Day -3 and Day -1 * Body mass index (BMI) of 18.5 -25 kg/m\^2 (both inclusive) * Negative serology for human immunodeficiency virus (HIV) antibody, hepatitis B (surface antigen), hepatitis C antibody, and syphilis bacteria * Healthy according to medical history, physical examination, gynaecological examination, ECG, blood pressure, and laboratory profile of blood and urine * Negative urine drug screen and alcohol breath test at screening and on Day -1 * Non-smoker or light smoker (≤ 5 cigarettes/day) for at least 6 months prior to trial
Exclusion criteria
* Presence or a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems, or presence or history of clinically significant reproductive, psychiatric, immunological, endocrine or metabolic diseases * Cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin * Pregnancy or breastfeeding * Current or a history of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or other ovarian dysfunction, tumours of the pituitary gland or hypothalamus, thyroid or adrenal disease * Clinically significant findings on the trans-vaginal ultrasound, cytology, gynaecological or breast examination at screening or on Day -1 including ovarian cysts or tumours of the ovaries or uterus * Contraindications for the use of gonadotropins and gonadotropin-releasing hormone (GnRH) agonists * Previously treated with gonadotropins within the last 6 months prior to screening * History within the last two years or current abuse of alcohol or drugs * Presence or history of severe allergy or anaphylactic reactions * Intake of prescribed medication, over-the-counter (OTC) medication, or herbal medicines, with the exceptions of COC, cromoglycate, and paracetamol according to the labelling, within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first dose of DECAPEPTYL Depot. Topical treatments of bacterial or fungal infection are allowed if stopped before first dose of IMP * Intake of any non-registered investigational drug within the last 12 weeks preceding screening, or longer if judged by the investigator to possibly influence the outcome of the current trial * High daily consumption of caffeine-containing beverages (e.g. more than five cups of coffee or equivalent) with a risk of withdrawal symptoms arising during the trial that may confound the safety evaluation * Blood donation or major blood loss (greater than equal to \[≥\]500 mL) within the last 8 weeks, or plasma donation with the last 4 weeks preceding the first day of IMP dosing * Current non-smokers or light smoker with a history of long-term, heavy smoking (\>10 pack-years) * Previously dosed in this trial * Mental incapacity or language barrier precluding adequate understanding or co-operation * Considered by the investigator to be unsuitable to participate in the trial for any other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC) | At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose | Area under the concentration-time curve from dosing to infinity. |
| Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt) | At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose | AUCt is defined as the area under the serum concentration-time curve from dosing up to time t, where t is the last time point at which the concentration is above the lower limit of quantification. |
| Maximum Serum Concentration Observed (Cmax) | At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose | Maximum concentration observed in serum. |
| Time of Maximum Observed Serum Concentration (Tmax) | At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose | Time of maximum observed concentration in serum. |
| Apparent Total Systemic Clearance (CL/F) | At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose | — |
| Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F) | At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose | — |
| Terminal Elimination Half-life (t½) | At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG) | At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11) | Number of participants with clinically significant abnormal changes in ECG are presented. |
| Number of Participants With Clinically Significant Abnormal Changes in Vital Signs | At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11) | Number of participants with clinically significant abnormal changes in vital signs (systemic blood pressures, heart rate and body temperature) are presented. |
| Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | At screening, on Day -1 and Day 3, and at the follow-up visit (Day 11) | Number of participants with clinically significant abnormal findings in laboratory parameters (clinical chemistry, haematology, urinalysis) are presented. |
| Number of Participants With Adverse Events (AEs) and Type of AEs | From signed informed consent until the end-of-trial visit (Day 28) | An AE is any untoward medical occurrence in a participant participating in a clinical trial. Number of participants with any AE (serious or non-serious) and type of AEs ( mild, moderate, severe) are presented. |
| Frequency of Injection Site Reactions | Immediately, 30 minutes, and 24 hours after administration | The injection site reactions (redness, pain, itching, swelling, and bruising) will be assessed by the investigator after injection, 30 minutes, and 24 hours after administration of the IMP. Each injection site reaction will be assessed as none, mild, moderate, or severe. |
| Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies | On Day 1 predose, Day 7, and Day 28 | — |
Countries
China
Participant flow
Recruitment details
The trial was conducted at one site in China between June 2019 to December 2019.
Pre-assignment details
A total of 133 subjects were screened, wherein, 24 subjects met the eligibility criteria and were randomized to the investigational medicinal product (IMP): 8 subjects each were exposed to Follitropin Delta (FE 999049) 12 μg, 18 μg and 24 μg, respectively. All the randomized subjects completed the trial.
Participants by arm
| Arm | Count |
|---|---|
| Follitropin Delta (FE 999049) 12 μg Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period. | 8 |
| Follitropin Delta (FE 999049) 18 μg Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period. | 8 |
| Follitropin Delta (FE 999049) 24 μg Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period. | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Follitropin Delta (FE 999049) 12 μg | Follitropin Delta (FE 999049) 18 μg | Follitropin Delta (FE 999049) 24 μg | Total |
|---|---|---|---|---|
| Age, Continuous | 28.6 years STANDARD_DEVIATION 6 | 29.5 years STANDARD_DEVIATION 6.7 | 25.4 years STANDARD_DEVIATION 4.6 | 27.8 years STANDARD_DEVIATION 5.8 |
| Body Mass Index (BMI) | 22.2 kg/m^2 STANDARD_DEVIATION 1.6 | 20.7 kg/m^2 STANDARD_DEVIATION 1.9 | 22.0 kg/m^2 STANDARD_DEVIATION 2.3 | 21.6 kg/m^2 STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 8 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 8 Participants | 8 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 8 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 5 / 8 | 4 / 8 | 3 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Apparent Total Systemic Clearance (CL/F)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Population: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Apparent Total Systemic Clearance (CL/F) | 0.301 Liter/hour | Geometric Coefficient of Variation 46.6 |
| Follitropin Delta (FE 999049) 18 μg | Apparent Total Systemic Clearance (CL/F) | 0.286 Liter/hour | Geometric Coefficient of Variation 19.7 |
| Follitropin Delta (FE 999049) 24 μg | Apparent Total Systemic Clearance (CL/F) | 0.289 Liter/hour | Geometric Coefficient of Variation 36.6 |
Primary
Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Population: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F) | 25.5 Liter | Geometric Coefficient of Variation 19.5 |
| Follitropin Delta (FE 999049) 18 μg | Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F) | 20.8 Liter | Geometric Coefficient of Variation 43.5 |
| Follitropin Delta (FE 999049) 24 μg | Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F) | 25.4 Liter | Geometric Coefficient of Variation 31.5 |
Primary
Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC)
Area under the concentration-time curve from dosing to infinity.
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Population: The per-protocol (PP) analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC) | 41.3 h*ng/mL | Geometric Coefficient of Variation 44.3 |
| Follitropin Delta (FE 999049) 18 μg | Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC) | 62.9 h*ng/mL | Geometric Coefficient of Variation 19.7 |
| Follitropin Delta (FE 999049) 24 μg | Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC) | 83.1 h*ng/mL | Geometric Coefficient of Variation 36.6 |
Primary
Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt)
AUCt is defined as the area under the serum concentration-time curve from dosing up to time t, where t is the last time point at which the concentration is above the lower limit of quantification.
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Population: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt) | 36.4 h*ng/mL | Geometric Coefficient of Variation 38 |
| Follitropin Delta (FE 999049) 18 μg | Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt) | 56.6 h*ng/mL | Geometric Coefficient of Variation 18.7 |
| Follitropin Delta (FE 999049) 24 μg | Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt) | 74.6 h*ng/mL | Geometric Coefficient of Variation 35.9 |
Primary
Maximum Serum Concentration Observed (Cmax)
Maximum concentration observed in serum.
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Population: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Maximum Serum Concentration Observed (Cmax) | 0.388 ng/mL | Geometric Coefficient of Variation 26.5 |
| Follitropin Delta (FE 999049) 18 μg | Maximum Serum Concentration Observed (Cmax) | 0.677 ng/mL | Geometric Coefficient of Variation 29.1 |
| Follitropin Delta (FE 999049) 24 μg | Maximum Serum Concentration Observed (Cmax) | 0.825 ng/mL | Geometric Coefficient of Variation 34.6 |
Primary
Terminal Elimination Half-life (t½)
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Population: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Terminal Elimination Half-life (t½) | 58.6 hour | Geometric Coefficient of Variation 47.5 |
| Follitropin Delta (FE 999049) 18 μg | Terminal Elimination Half-life (t½) | 50.5 hour | Geometric Coefficient of Variation 43.5 |
| Follitropin Delta (FE 999049) 24 μg | Terminal Elimination Half-life (t½) | 60.9 hour | Geometric Coefficient of Variation 13.6 |
Primary
Time of Maximum Observed Serum Concentration (Tmax)
Time of maximum observed concentration in serum.
Time frame: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Population: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Time of Maximum Observed Serum Concentration (Tmax) | 24.0 hour |
| Follitropin Delta (FE 999049) 18 μg | Time of Maximum Observed Serum Concentration (Tmax) | 24.0 hour |
| Follitropin Delta (FE 999049) 24 μg | Time of Maximum Observed Serum Concentration (Tmax) | 24.0 hour |
Secondary
Frequency of Injection Site Reactions
The injection site reactions (redness, pain, itching, swelling, and bruising) will be assessed by the investigator after injection, 30 minutes, and 24 hours after administration of the IMP. Each injection site reaction will be assessed as none, mild, moderate, or severe.
Time frame: Immediately, 30 minutes, and 24 hours after administration
Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Frequency of Injection Site Reactions | 0 Participants |
| Follitropin Delta (FE 999049) 18 μg | Frequency of Injection Site Reactions | 0 Participants |
| Follitropin Delta (FE 999049) 24 μg | Frequency of Injection Site Reactions | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Type of AEs
An AE is any untoward medical occurrence in a participant participating in a clinical trial. Number of participants with any AE (serious or non-serious) and type of AEs ( mild, moderate, severe) are presented.
Time frame: From signed informed consent until the end-of-trial visit (Day 28)
Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Moderate AEs | 0 Participants |
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Mild AEs | 5 Participants |
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Adverse events (AEs) | 5 Participants |
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Serious AEs | 0 Participants |
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Severe AEs | 0 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Mild AEs | 3 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Adverse events (AEs) | 4 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Serious AEs | 0 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Moderate AEs | 1 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Severe AEs | 0 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Severe AEs | 0 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Moderate AEs | 0 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Adverse events (AEs) | 3 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Mild AEs | 3 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Adverse Events (AEs) and Type of AEs | Serious AEs | 0 Participants |
Secondary
Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG)
Number of participants with clinically significant abnormal changes in ECG are presented.
Time frame: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG) | 0 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG) | 0 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG) | 1 Participants |
Secondary
Number of Participants With Clinically Significant Abnormal Changes in Vital Signs
Number of participants with clinically significant abnormal changes in vital signs (systemic blood pressures, heart rate and body temperature) are presented.
Time frame: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)
Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Clinically Significant Abnormal Changes in Vital Signs | 0 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Clinically Significant Abnormal Changes in Vital Signs | 0 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Clinically Significant Abnormal Changes in Vital Signs | 0 Participants |
Secondary
Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters
Number of participants with clinically significant abnormal findings in laboratory parameters (clinical chemistry, haematology, urinalysis) are presented.
Time frame: At screening, on Day -1 and Day 3, and at the follow-up visit (Day 11)
Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | Haematology | 0 Participants |
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | Clinical Chemistry | 2 Participants |
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | Urinalysis | 0 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | Haematology | 1 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | Clinical Chemistry | 1 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | Urinalysis | 1 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | Clinical Chemistry | 1 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | Urinalysis | 0 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters | Haematology | 0 Participants |
Secondary
Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies
Time frame: On Day 1 predose, Day 7, and Day 28
Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Follitropin Delta (FE 999049) 12 μg | Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies | 0 Participants |
| Follitropin Delta (FE 999049) 18 μg | Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies | 0 Participants |
| Follitropin Delta (FE 999049) 24 μg | Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies | 0 Participants |