Trial · NCT02317809
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC 0-t,Adj) for Follicle-Stimulating Hormone (FSH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period | Pharmacokinetic (PK) analysis set: All randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully down regulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays. | International units*hour/liter (IU*h/L) | GEOMETRIC_MEAN |
| PRIMARY | Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-t,Adj) for Luteinizing Hormone (LH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period | Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays. | International units*hour/liter (IU*h/L) | GEOMETRIC_MEAN |
| PRIMARY | Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Follicle-Stimulating Hormone (FSH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period | Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays. | International units per liter (IU/L) | GEOMETRIC_MEAN |
| PRIMARY | Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Luteinizing Hormone (LH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period | Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays. | International units per liter (IU/L) | GEOMETRIC_MEAN |
| SECONDARY | Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC0-inf, Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH | PK analysis set. Here n signifies those subjects who were evaluable for the specified hormone level in each arm, respectively. | International units*hour/liter (IU*h/L) | GEOMETRIC_MEAN |
| SECONDARY | Baseline Corrected Area Under the Serum Concentration-time Curve From Time Tlast Extrapolated to Infinity (%AUCextra,Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH | As per statistical analysis plan, data was not planned to be summarized because AUCextra,adj was below 20% for all the participants. | ||
| SECONDARY | Apparent Terminal Elimination Rate Constant (Lambda[z]) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH | PK analysis set. Here n signifies those subjects who were evaluable for the specified hormone level in each arm, respectively. | Per Hour (1/hour) | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach the Maximum Serum Concentration (Tmax) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH | Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays. | Hour (h) | MEDIAN |
| SECONDARY | Apparent Terminal Half-life (t1/2) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH | PK analysis set. Here n signifies those subjects who were evaluable for the specified hormone level in each arm, respectively. | Hour (h) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Serum Clearance (CL/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH | PK analysis set. Here n signifies those subjects who were evaluable for the specified hormone level in each arm, respectively. | Liter per hour (L/h) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution During Terminal Phase (Vz/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH) | Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH | PK analysis set. Here n signifies those subjects who were evaluable for the specified hormone level in each arm, respectively. | Liter (L) | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods | Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Laboratory Assessments, Vital Signs or Electrocardiogram Findings | Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods | Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Follicle Size Greater Than (>)13 Millimeter | Day 1 (pre-dose) up to follow-up visit (Day 18) for IMP intervention periods | Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). | Subjects | NUMBER |
| SECONDARY | Serum Estradiol Levels | Screening (up to 28 days), Day 1 (pre-dose) and Day 8 in Period 1, Day 1 (pre-dose), Day 8 and follow-up (Day 18) in Period 2 | Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). | nanogram per liter (ng/L) | MEAN |
| SECONDARY | Number of Subjects With Local Tolerability/Injection Site Reactions (ISRs) | 5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period | Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here n signifies those subjects who were evaluable for the specified injection site reaction at the specified time point for each arm, respectively. | Subjects | NUMBER |
| SECONDARY | Pain Visual Analogue Scale (VAS) Score | 5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period | Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here n signifies those subjects who were evaluable for the specified time point in each arm, respectively. | mm | MEAN |
| SECONDARY | Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Luteinizing Hormone (LH) | Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods | Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). | Subjects | NUMBER |
| SECONDARY | Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) Titers for Luteinizing Hormone (LH) | Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods | Data could not be collected as there were no subjects with positive results for ADAs and NAbs. | ||
| SECONDARY | Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Follicle-stimulating Hormone (FSH) | Day 1 pre-dose and Day 8 post-dose for IMP intervention periods | Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here n signifies those subjects who were evaluable for the specified hormone level in each arm, respectively. | Subjects | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT02317809/outcomes