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Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive

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ClinicalTrials.gov Identifier: NCT00898560
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Partial Epilepsy
Interventions Drug: eslicarbazepine acetate and Microginon®
Drug: Microginon®
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ESL and Microginon®
Hide Arm/Group Description

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

Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Arm/Group Title ESL and Microginon®
Hide Arm/Group Description

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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Cmax - Maximum Observed Plasma Concentration
Hide Description 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).
Time Frame 15-day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Microginon® ESL and Microginon®
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: pg/mL
Cmax (ethinyloestradiol) 82.4  (23.4) 75.0  (26.8)
Cmax (levonogestrel) 4170  (1720) 4340  (1530)
2.Secondary Outcome
Title 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
Hide Description 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).
Time Frame 15-day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Microginon® ESL and Microginon®
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
AUC0-t (ethinyloestradiol) 0.665  (0.195) 0.453  (0.167)
AUC0-t (levonogestrel) 37.4  (19.1) 32.0  (12.9)
3.Secondary Outcome
Title AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
Hide Description 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).
Time Frame 15-day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Microginon® ESL and Microginon®
Hide Arm/Group Description:

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)

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 Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
AUC0-∞ (ethinyloestradiol) 0.768  (0.223) 0.533  (0.181)
AUC0-∞ (levonorgestrel) 52.1  (22.1) 43.1  (13.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ESL and Microginon® Microginon®
Hide Arm/Group Description

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

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)

All-Cause Mortality
ESL and Microginon® Microginon®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
ESL and Microginon® Microginon®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ESL and Microginon® Microginon®
Affected / at Risk (%) Affected / at Risk (%)
Total   18/20 (90.00%)   8/20 (40.00%) 
Eye disorders     
Xerophthalmia  2/20 (10.00%)  0/20 (0.00%) 
Gastrointestinal disorders     
Constipation  1/20 (5.00%)  0/20 (0.00%) 
Dry throat  1/20 (5.00%)  0/20 (0.00%) 
Dyspepsia  1/20 (5.00%)  0/20 (0.00%) 
Hypoaesthesia oral  2/20 (10.00%)  0/20 (0.00%) 
Nausea  5/20 (25.00%)  0/20 (0.00%) 
Paraesthesia oral  5/20 (25.00%)  0/20 (0.00%) 
Toothache  0/20 (0.00%)  1/20 (5.00%) 
Vomiting  2/20 (10.00%)  0/20 (0.00%) 
General disorders     
Vessel puncture site haematoma  0/20 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Upper respiratory tract infection  4/20 (20.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications     
Heat stroke  1/20 (5.00%)  0/20 (0.00%) 
Investigations     
Blood creatine phosphokinase increased  2/20 (10.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1/20 (5.00%)  0/20 (0.00%) 
Joint range of motion decreased  2/20 (10.00%)  0/20 (0.00%) 
Musculoskeletal pain  1/20 (5.00%)  0/20 (0.00%) 
Nervous system disorders     
Diplopia  1/20 (5.00%)  0/20 (0.00%) 
Dizziness  5/20 (25.00%)  0/20 (0.00%) 
Headache  6/20 (30.00%)  2/20 (10.00%) 
Somnolence  8/20 (40.00%)  2/20 (10.00%) 
Syncope  1/20 (5.00%)  0/20 (0.00%) 
Tremor  1/20 (5.00%)  0/20 (0.00%) 
Psychiatric disorders     
Anxiety  1/20 (5.00%)  0/20 (0.00%) 
Libido increased  1/20 (5.00%)  0/20 (0.00%) 
Renal and urinary disorders     
Dysuria  1/20 (5.00%)  0/20 (0.00%) 
Reproductive system and breast disorders     
Metrorrhagia  0/20 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthmatic crisis  1/20 (5.00%)  0/20 (0.00%) 
Cough  0/20 (0.00%)  2/20 (10.00%) 
Throat irritation  1/20 (5.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Cheilitis  1/20 (5.00%)  0/20 (0.00%) 
Rash macular  1/20 (5.00%)  0/20 (0.00%) 
Social circumstances     
Sexual activity increased  1/20 (5.00%)  0/20 (0.00%) 
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Research
Organization: Bial – Portela & Cª, S.A.
Phone: +351 229 866 100
EMail: jose.rocha@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00898560    
Other Study ID Numbers: BIA-2093-128
First Submitted: May 11, 2009
First Posted: May 12, 2009
Results First Submitted: December 5, 2014
Results First Posted: December 12, 2014
Last Update Posted: December 12, 2014