Trial Outcomes & Findings for Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive (NCT NCT00898560)
NCT ID: NCT00898560
Last Updated: 2014-12-12
Results Overview
To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
15-day
Results posted on
2014-12-12
Participant Flow
Participant milestones
| Measure |
ESL and Microginon®
15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive
Baseline characteristics by cohort
| Measure |
ESL and Microginon®
n=20 Participants
15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 15-dayTo investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
Outcome measures
| Measure |
Microginon®
n=19 Participants
A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
|
ESL and Microginon®
n=19 Participants
15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period
|
|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
Cmax (ethinyloestradiol)
|
82.4 pg/mL
Standard Deviation 23.4
|
75.0 pg/mL
Standard Deviation 26.8
|
|
Cmax - Maximum Observed Plasma Concentration
Cmax (levonogestrel)
|
4170 pg/mL
Standard Deviation 1720
|
4340 pg/mL
Standard Deviation 1530
|
SECONDARY outcome
Timeframe: 15-dayTo investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
Outcome measures
| Measure |
Microginon®
n=19 Participants
A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
|
ESL and Microginon®
n=19 Participants
15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period
|
|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification
AUC0-t (ethinyloestradiol)
|
0.665 ng.h/mL
Standard Deviation 0.195
|
0.453 ng.h/mL
Standard Deviation 0.167
|
|
AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification
AUC0-t (levonogestrel)
|
37.4 ng.h/mL
Standard Deviation 19.1
|
32.0 ng.h/mL
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 15-dayTo investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
Outcome measures
| Measure |
Microginon®
n=19 Participants
A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
|
ESL and Microginon®
n=19 Participants
15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period
|
|---|---|---|
|
AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
AUC0-∞ (ethinyloestradiol)
|
0.768 ng.h/mL
Standard Deviation 0.223
|
0.533 ng.h/mL
Standard Deviation 0.181
|
|
AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
AUC0-∞ (levonorgestrel)
|
52.1 ng.h/mL
Standard Deviation 22.1
|
43.1 ng.h/mL
Standard Deviation 13.3
|
Adverse Events
ESL and Microginon®
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Microginon®
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ESL and Microginon®
n=20 participants at risk
15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period
|
Microginon®
n=20 participants at risk
A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).
Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
|
|---|---|---|
|
Eye disorders
Xerophthalmia
|
10.0%
2/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Dry throat
|
5.0%
1/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
10.0%
2/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Paraesthesia oral
|
25.0%
5/20
|
0.00%
0/20
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20
|
5.0%
1/20
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20
|
0.00%
0/20
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/20
|
5.0%
1/20
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
4/20
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Heat stroke
|
5.0%
1/20
|
0.00%
0/20
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
2/20
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
10.0%
2/20
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20
|
0.00%
0/20
|
|
Nervous system disorders
Diplopia
|
5.0%
1/20
|
0.00%
0/20
|
|
Nervous system disorders
Dizziness
|
25.0%
5/20
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
30.0%
6/20
|
10.0%
2/20
|
|
Nervous system disorders
Somnolence
|
40.0%
8/20
|
10.0%
2/20
|
|
Nervous system disorders
Syncope
|
5.0%
1/20
|
0.00%
0/20
|
|
Nervous system disorders
Tremor
|
5.0%
1/20
|
0.00%
0/20
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20
|
0.00%
0/20
|
|
Psychiatric disorders
Libido increased
|
5.0%
1/20
|
0.00%
0/20
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/20
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
5.0%
1/20
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.0%
1/20
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
5.0%
1/20
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.0%
1/20
|
0.00%
0/20
|
|
Social circumstances
Sexual activity increased
|
5.0%
1/20
|
0.00%
0/20
|
Additional Information
Head of Clinical Research
Bial - Portela & Cª, S.A.
Phone: +351 229 866 100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place