Trial · NCT02080468
Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
NCT02080468, Phase 1, Completed, Aegerion Pharmaceuticals, Inc.; results first posted 2019-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects. Trials, record NCT02080468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02080468
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
- NCT number
- NCT02080468
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Conditions
- Healthy
- Interventions
- lomitapide, EE/norgestimate
- First posted
- 2014-03-06
- Last updated
- 2019-03-11
- Results first posted
- 2019-03-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3 |
| Primary | Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3. |
| Primary | AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 \& M3. |
| Primary | AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 \& M3. |
| Primary | t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 \& M3. |
| Secondary | Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3. |
| Secondary | Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3. |
| Secondary | AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 \& M3. |
| Secondary | AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 \& M3. |
| Secondary | t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | Apparent terminal elimination half-life of lomitapide and its metabolites, M1 \& M3. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | hr | MEDIAN |
| PRIMARY | AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | ng*hr/mL | GEOMETRIC_MEAN |
| PRIMARY | AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | ng*hr/mL | GEOMETRIC_MEAN |
| PRIMARY | t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | hr | GEOMETRIC_MEAN |
| SECONDARY | Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | hr | MEAN |
| SECONDARY | AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart) | 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing | The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses. | hr | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of Lomitapide (Lomitapide Alone) | 1.03 | Geometric Coefficient of Variation 39.1 | ng/mL | |
| Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of Lomitapide (Coadministered Simultaneously) | 1.39 | Geometric Coefficient of Variation 58.4 | ng/mL | |
| Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of M1 (Lomitapide Alone) | 2.96 | Geometric Coefficient of Variation 27.0 | ng/mL | |
| Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of M1 (Coadministered Simultaneously) | 2.95 | Geometric Coefficient of Variation 19.4 | ng/mL | |
| Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of M3 (Lomitapide Alone) | 36.3 | Geometric Coefficient of Variation 32.1 | ng/mL | |
| Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of M3 (Coadministered Simultaneously) | 34.0 | Geometric Coefficient of Variation 27.9 | ng/mL | |
| Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of Lomitapide (Lomitapide Alone) | 6.00 | Full Range 4.00 to 12.0 | hr | |
| Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of Lomitapide (Coadministered Simultaneously) | 5.00 | Full Range 1.00 to 18.0 | hr | |
| Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of M1 (Lomitapide Alone) | 8.28 | Full Range 5.00 to 12.0 | hr | |
| Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) | PK of M1 (Coadministered Simultaneously) | 6.00 | Full Range 2.00 to 12.0 | hr |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lomitapide & EE/Norgestimate - Taken Together | 16 | |
| Overall Study | STARTED | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 16 | |
| Overall Study | COMPLETED | Lomitapide & EE/Norgestimate - Taken Together | 14 | |
| Overall Study | COMPLETED | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 14 | |
| Overall Study | NOT COMPLETED | Lomitapide & EE/Norgestimate - Taken Together | 2 | |
| Overall Study | NOT COMPLETED | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 2 |
Source ClinicalTrials.gov
Adverse events52
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 | Nausea | Gastrointestinal disorders | Lomitapide & EE/Norgestimate - Taken Together | 4 | 16 | 5 |
| other | Nausea | Gastrointestinal disorders | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 1 | 16 | 1 |
| other | Vomitting | Gastrointestinal disorders | Lomitapide & EE/Norgestimate - Taken Together | 4 | 16 | 4 |
| other | Vomitting | Gastrointestinal disorders | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 1 | 16 | 1 |
| other | Headache | Nervous system disorders | Lomitapide & EE/Norgestimate - Taken Together | 2 | 16 | 2 |
| other | Headache | Nervous system disorders | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 3 | 16 | 3 |
| other | Procedural dizziness | Injury, poisoning and procedural complications | Lomitapide & EE/Norgestimate - Taken Together | 1 | 16 | 1 |
| other | Procedural dizziness | Injury, poisoning and procedural complications | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 2 | 16 | 2 |
| other | Procedural Nausea | Injury, poisoning and procedural complications | Lomitapide & EE/Norgestimate - Taken Together | 0 | 16 | 0 |
| other | Procedural Nausea | Injury, poisoning and procedural complications | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 2 | 16 | 2 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lomitapide & EE/Norgestimate - Taken Together | 0 | 16 |
| Total, all-cause mortality | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 0 | 16 |
| Total, other adverse events | Lomitapide & EE/Norgestimate - Taken Together | 8 | 16 |
| Total, other adverse events | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 7 | 16 |
| Total, serious adverse events | Lomitapide & EE/Norgestimate - Taken Together | 0 | 16 |
| Total, serious adverse events | Lomitapide & EE/Norgestimate - Taken 12 Hours Apart | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lomitapide & EE/Norgestimate - Taken Together vs Lomitapide & EE/Norgestimate - Taken 12 Hours Apart: deaths from any cause | Trial comparisons |
| Lomitapide & EE/Norgestimate - Taken Together vs Lomitapide & EE/Norgestimate - Taken 12 Hours Apart: serious adverse events | 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/NCT02080468
GET https://conductscience.org/api/trials/v1/NCT02080468/results?page=2