Trial Outcomes & Findings for Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects (NCT NCT02080468)

NCT ID: NCT02080468

Last Updated: 2019-03-11

Results Overview

Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Results posted on

2019-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Lomitapide & EE/Norgestimate - Taken Together 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28) lomitapide: 20 mg EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet	Lomitapide & EE/Norgestimate - Taken 12 Hours Apart 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29) lomitapide: 20 mg EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet
Overall Study STARTED	16	16
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lomitapide & EE/Norgestimate - Taken Together n=16 Participants 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28) lomitapide: 20 mg EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet	Lomitapide & EE/Norgestimate - Taken 12 Hours Apart n=16 Participants 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29) lomitapide: 20 mg EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30 years STANDARD_DEVIATION 6.4 • n=5 Participants	29 years STANDARD_DEVIATION 5.7 • n=7 Participants	29 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)	1.03 ng/mL Geometric Coefficient of Variation 39.1	1.39 ng/mL Geometric Coefficient of Variation 58.4	2.96 ng/mL Geometric Coefficient of Variation 27.0	2.95 ng/mL Geometric Coefficient of Variation 19.4	36.3 ng/mL Geometric Coefficient of Variation 32.1	34.0 ng/mL Geometric Coefficient of Variation 27.9

PRIMARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 \& M3.

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)	6.00 hr Interval 4.0 to 12.0	5.00 hr Interval 1.0 to 18.0	8.28 hr Interval 5.0 to 12.0	6.00 hr Interval 2.0 to 12.0	5.02 hr Interval 3.0 to 12.0	3.97 hr Interval 1.0 to 6.0

PRIMARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 \& M3.

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)	33.5 ng*hr/mL Geometric Coefficient of Variation 35.0	42.7 ng*hr/mL Geometric Coefficient of Variation 49.5	89.3 ng*hr/mL Geometric Coefficient of Variation 35.6	96.8 ng*hr/mL Geometric Coefficient of Variation 32.1	456 ng*hr/mL Geometric Coefficient of Variation 41.2	371 ng*hr/mL Geometric Coefficient of Variation 36.1

PRIMARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 \& M3.

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)	36.5 ng*hr/mL Geometric Coefficient of Variation 34.8	46.5 ng*hr/mL Geometric Coefficient of Variation 49.1	91.4 ng*hr/mL Geometric Coefficient of Variation 35.8	99.4 ng*hr/mL Geometric Coefficient of Variation 32.4	463 ng*hr/mL Geometric Coefficient of Variation 40.9	377 ng*hr/mL Geometric Coefficient of Variation 36.0

PRIMARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 \& M3.

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)	51.0 hr Geometric Coefficient of Variation 16.1	53.6 hr Geometric Coefficient of Variation 19.0	32.5 hr Geometric Coefficient of Variation 20.3	36.8 hr Geometric Coefficient of Variation 30.3	38.3 hr Geometric Coefficient of Variation 32.7	39.8 hr Geometric Coefficient of Variation 26.2

SECONDARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3.

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)	1.05 ng/mL Geometric Coefficient of Variation 50.7	1.39 ng/mL Geometric Coefficient of Variation 56.5	2.87 ng/mL Geometric Coefficient of Variation 20.6	3.04 ng/mL Geometric Coefficient of Variation 22.8	37.8 ng/mL Geometric Coefficient of Variation 26.2	33.0 ng/mL Geometric Coefficient of Variation 28.0

SECONDARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 \& M3.

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)	8.00 hr Interval 5.0 to 10.0	8.00 hr Interval 3.0 to 11.8	9.07 hr Interval 5.0 to 12.0	8.00 hr Interval 3.0 to 11.9	6.00 hr Interval 5.0 to 10.0	5.50 hr Interval 2.0 to 8.4

SECONDARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 \& M3.

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)	37.6 ng*hr/mL Geometric Coefficient of Variation 49.9	46.5 ng*hr/mL Geometric Coefficient of Variation 55.1	92.3 ng*hr/mL Geometric Coefficient of Variation 31.1	93.7 ng*hr/mL Geometric Coefficient of Variation 34.2	520 ng*hr/mL Geometric Coefficient of Variation 30.1	377 ng*hr/mL Geometric Coefficient of Variation 31.9

SECONDARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 \& M3.

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)	41.1 ng*hr/mL Geometric Coefficient of Variation 50.9	51.2 ng*hr/mL Geometric Coefficient of Variation 55.3	94.5 ng*hr/mL Geometric Coefficient of Variation 31.3	96.4 ng*hr/mL Geometric Coefficient of Variation 34.6	528 ng*hr/mL Geometric Coefficient of Variation 30.0	383 ng*hr/mL Geometric Coefficient of Variation 31.7

SECONDARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing

Population: The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.

Apparent terminal elimination half-life of lomitapide and its metabolites, M1 \& M3.

Outcome measures

Outcome measures
Measure	PK of Lomitapide (Lomitapide Alone) n=16 Participants PK of lomitapide following administration of lomitapide alone	PK of Lomitapide (Coadministered Simultaneously) n=14 Participants PK of lomitapide following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M1 (Lomitapide Alone) n=16 Participants PK of M1 following administration of lomitapide alone	PK of M1 (Coadministered Simultaneously) n=14 Participants PK of M1 following administration of lomitapide coadministered with EE/Norgestimate simultaneously	PK of M3 (Lomitapide Alone) n=16 Participants PK of M3 following administration of lomitapide alone	PK of M3 (Coadministered Simultaneously) n=14 Participants PK of M3 following administration of lomitapide coadministered with EE/Norgestimate simultaneously
t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)	51.0 hr Geometric Coefficient of Variation 22.2	52.0 hr Geometric Coefficient of Variation 16.1	36.2 hr Geometric Coefficient of Variation 21.0	37.2 hr Geometric Coefficient of Variation 19.1	38.0 hr Geometric Coefficient of Variation 28.0	33.6 hr Geometric Coefficient of Variation 23.2

Adverse Events

Lomitapide & EE/Norgestimate - Taken Together

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Lomitapide & EE/Norgestimate - Taken 12 Hours Apart

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lomitapide & EE/Norgestimate - Taken Together n=16 participants at risk 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 8 through day 28) lomitapide: 20 mg EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet	Lomitapide & EE/Norgestimate - Taken 12 Hours Apart n=16 participants at risk 2 single oral doses of lomitapide (20 mg) (Day 1 \& Day 22) 21 single oral doses of EE/Norgestimate(Day 9 through day 29) lomitapide: 20 mg EE/norgestimate: 1x0.035-mg EE/0.25-mg norgestimate tablet
Gastrointestinal disorders Nausea	25.0% 4/16 • Number of events 5	6.2% 1/16 • Number of events 1
Gastrointestinal disorders Vomitting	25.0% 4/16 • Number of events 4	6.2% 1/16 • Number of events 1
Nervous system disorders Headache	12.5% 2/16 • Number of events 2	18.8% 3/16 • Number of events 3
Injury, poisoning and procedural complications Procedural dizziness	6.2% 1/16 • Number of events 1	12.5% 2/16 • Number of events 2
Injury, poisoning and procedural complications Procedural Nausea	0.00% 0/16	12.5% 2/16 • Number of events 2
Injury, poisoning and procedural complications Laceration	6.2% 1/16 • Number of events 1	0.00% 0/16
General disorders Vessel Punction Site Pain	12.5% 2/16 • Number of events 2	0.00% 0/16
Psychiatric disorders Insomnia	0.00% 0/16	6.2% 1/16 • Number of events 1
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Number of events 1	0.00% 0/16
Gastrointestinal disorders Abdominal pain upper	6.2% 1/16 • Number of events 1	0.00% 0/16
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • Number of events 1	0.00% 0/16
Nervous system disorders Presyncope	6.2% 1/16 • Number of events 1	0.00% 0/16
Nervous system disorders Sensory disturbance	0.00% 0/16	6.2% 1/16 • Number of events 1
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/16	12.5% 2/16 • Number of events 2
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/16	6.2% 1/16 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/16	6.2% 1/16 • Number of events 1
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/16	6.2% 1/16 • Number of events 1
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/16	6.2% 1/16 • Number of events 1
Reproductive system and breast disorders Dysmenorrhoea	12.5% 2/16 • Number of events 3	0.00% 0/16
Skin and subcutaneous tissue disorders Rash	0.00% 0/16	6.2% 1/16 • Number of events 2
Skin and subcutaneous tissue disorders hyperhidrosis	0.00% 0/16	6.2% 1/16 • Number of events 1
Infections and infestations Fungal infection	6.2% 1/16 • Number of events 1	0.00% 0/16
Investigations Body temperature increased	0.00% 0/16	6.2% 1/16 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	6.2% 1/16 • Number of events 1	0.00% 0/16
Renal and urinary disorders Dysuria	6.2% 1/16 • Number of events 1	0.00% 0/16
Vascular disorders Hot flush	6.2% 1/16 • Number of events 1	0.00% 0/16

Additional Information

Alison Long, MD - VP Clinical

Aegerion Pharmaceuticals, Inc.

Phone: 617-500-5142

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Described in site contract
Publication restrictions are in place

Restriction type: OTHER