Trial · NCT02317809
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
NCT02317809, Phase 1, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2016-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects. Trials, record NCT02317809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02317809
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
- NCT number
- NCT02317809
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 34 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Healthy
- Interventions
- Liquid pergoveris, Freeze-dried pergoveris
- First posted
- 2014-12-16
- Last updated
- 2018-07-16
- Other registries' IDs
- eudract:2014-003506-32
- Results first posted
- 2016-12-13
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t - (baseline concentration \* t). |
| 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 | The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t - (baseline concentration \* t). |
| 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 | Baseline-corrected Cmax (Cmax,adj) = Cmax - baseline concentration |
| 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 | Baseline-corrected Cmax (Cmax,adj) = Cmax - baseline concentration. |
| 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 | |
| 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 | Area under the serum concentration-time curve from Tlast extrapolated to infinity given as a percentage of AUC0-inf. Data was not planned to be summarized if AUCextra,adj was less than 20%. |
| 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 | The elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data. |
| 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 | |
| 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 | Terminal half-life is the time measured for the concentration to decrease by one half. |
| 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 | Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained is influenced by the fraction of the dose absorbed and was expressed as volume (Liter) per unit of time (hour). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group157
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC 0-t,Adj) for Follicle-Stimulating Hormone (FSH) | Liquid Pergoveris | 3187.4 | Geometric Coefficient of Variation 24.3 | International units*hour/liter (IU*h/L) | |
| Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC 0-t,Adj) for Follicle-Stimulating Hormone (FSH) | Freeze-dried Pergoveris | 2775.4 | Geometric Coefficient of Variation 22.0 | International units*hour/liter (IU*h/L) | |
| Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-t,Adj) for Luteinizing Hormone (LH) | Liquid Pergoveris | 210.4 | Geometric Coefficient of Variation 25.8 | International units*hour/liter (IU*h/L) | |
| Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-t,Adj) for Luteinizing Hormone (LH) | Freeze-dried Pergoveris | 195.2 | Geometric Coefficient of Variation 22.5 | International units*hour/liter (IU*h/L) | |
| Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Follicle-Stimulating Hormone (FSH) | Liquid Pergoveris | 47.92 | Geometric Coefficient of Variation 27.3 | International units per liter (IU/L) | |
| Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Follicle-Stimulating Hormone (FSH) | Freeze-dried Pergoveris | 42.55 | Geometric Coefficient of Variation 29.0 | International units per liter (IU/L) | |
| Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Luteinizing Hormone (LH) | Liquid Pergoveris | 10.126 | Geometric Coefficient of Variation 31.1 | International units per liter (IU/L) | |
| Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Luteinizing Hormone (LH) | Freeze-dried Pergoveris | 9.782 | Geometric Coefficient of Variation 24.1 | International units per liter (IU/L) | |
| 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) | Liquid Pergoveris | Follicle-stimulating Hormone (n=22, 22) | 3366.6 | Geometric Coefficient of Variation 24.2 | International units*hour/liter (IU*h/L) |
| 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) | Freeze-dried Pergoveris | Follicle-stimulating Hormone (n=22, 22) | 2912.1 | Geometric Coefficient of Variation 22.2 | International units*hour/liter (IU*h/L) |
1 to 10 of 157Source ClinicalTrials.gov
See all 157 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention Period (8 Days) | STARTED | First Liquid Pergoveris, Then Freeze-dried Pergoveris | 17 | |
| First Intervention Period (8 Days) | STARTED | First Freeze-dried Pergoveris, Then Liquid Pergoveris | 17 | |
| First Intervention Period (8 Days) | COMPLETED | First Liquid Pergoveris, Then Freeze-dried Pergoveris | 14 | |
| First Intervention Period (8 Days) | COMPLETED | First Freeze-dried Pergoveris, Then Liquid Pergoveris | 17 | |
| First Intervention Period (8 Days) | NOT COMPLETED | First Liquid Pergoveris, Then Freeze-dried Pergoveris | 3 | |
| First Intervention Period (8 Days) | NOT COMPLETED | First Freeze-dried Pergoveris, Then Liquid Pergoveris | 0 | |
| Second Intervention Period (8 Days) | STARTED | First Liquid Pergoveris, Then Freeze-dried Pergoveris | 14 | |
| Second Intervention Period (8 Days) | STARTED | First Freeze-dried Pergoveris, Then Liquid Pergoveris | 17 | |
| Second Intervention Period (8 Days) | COMPLETED | First Liquid Pergoveris, Then Freeze-dried Pergoveris | 14 | |
| Second Intervention Period (8 Days) | COMPLETED | First Freeze-dried Pergoveris, Then Liquid Pergoveris | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | Liquid Pergoveris | 1 | 34 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Freeze-dried Pergoveris | 0 | 31 | |
| other | Nausea | Gastrointestinal disorders | Liquid Pergoveris | 1 | 34 | |
| other | Nausea | Gastrointestinal disorders | Freeze-dried Pergoveris | 3 | 31 | |
| other | Diarrhoea | Gastrointestinal disorders | Liquid Pergoveris | 1 | 34 | |
| other | Diarrhoea | Gastrointestinal disorders | Freeze-dried Pergoveris | 0 | 31 | |
| other | Constipation | Gastrointestinal disorders | Liquid Pergoveris | 0 | 34 | |
| other | Constipation | Gastrointestinal disorders | Freeze-dried Pergoveris | 1 | 31 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Liquid Pergoveris | 1 | 34 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Freeze-dried Pergoveris | 1 | 31 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liquid Pergoveris | ||
| Total, all-cause mortality | Freeze-dried Pergoveris | ||
| Total, other adverse events | Liquid Pergoveris | 12 | 34 |
| Total, other adverse events | Freeze-dried Pergoveris | 14 | 31 |
| Total, serious adverse events | Liquid Pergoveris | 1 | 34 |
| Total, serious adverse events | Freeze-dried Pergoveris | 0 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29375477 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Liquid Pergoveris vs Freeze-dried Pergoveris: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02317809
GET https://conductscience.org/api/trials/v1/NCT02317809/registered?page=2