CompletedNCT02281448Updated Dec 3, 2014Results posted

Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

A Phase 1 interventional study of BIA 2-093 and Contraceptives, Oral, Combined in Epilepsy, sponsored by Bial - Portela C S.A.. Completed at 1 site in Portugal. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by Bial - Portela C S.A. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study summary

Read the detailed description

Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 for 15 days separated by a washout period of at least 3 weeks.

Conditions studied

Epilepsy

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Epilepsy 1,805

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

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Lead sponsor

Bial - Portela C S.A. is the lead sponsor of 133 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Pre-menopausal female;
Able and willing to give written informed consent;
Aged 18 to 40 years, inclusive;
Not pregnant or breast-feeding;
Body mass index (BMI) between 19 and 30 kg/m2, inclusive;
Healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ECG;
Clinical laboratory tests with clinically acceptable results at screening and admission to the first period;
Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening;
Negative test for drugs of abuse at screening;
Non-smoker or smokes less than 10 cigarettes or equivalent per day;
Agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit;
Negative pregnancy test at screening and admission to the first period.

Exclusion criteria

Exclusion Criteria:

Had any contra-indication to the use of oral contraceptives;
Had experienced notable adverse events while on any oral contraceptive;
Had a history of alcoholism or drug abuse;
Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
Had acute gastrointestinal symptoms at the time of screening or admission to the first period;
Had a significant infection or inflammatory process at the time of screening or admission to the first period;
Had a relevant surgical history;
Had a relevant family history;
Had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine);
Had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period;
Consumed more than 14 units of alcohol a week;
Had participated in any clinical trial within 3 months prior to screening;
Had previously received BIA 2-093;
Had donated or received any blood or blood products within 2 months prior to screening;
Was unlikely to co-operate with the requirements of the study.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Other
Treatment sequence A
oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive
Drug: BIA 2-093 · Drug: Contraceptives, Oral, Combined
Other
Treatment sequence B
oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days
Drug: BIA 2-093 · Drug: Contraceptives, Oral, Combined

Interventions

DrugBIA 2-093
DrugContraceptives, Oral, Combined

What researchers measure

Primary outcomes

Cmax - Maximum Observed Plasma BIA 2-194 Concentration
Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
Time frame: Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.

Secondary outcomes

Cmax
Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
Time frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
Tmax
Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
Time frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
AUC0-t
AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)
Time frame: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.

Results

Posted Dec 3, 2014

Participant flow

Participant flow — Overall Study
Milestone	Treatment Sequence A	Treatment Sequence B
Started	10	10
Completed	8	9
Not completed	2	1

Outcome measures

PrimaryCmax - Maximum Observed Plasma BIA 2-194 Concentration

Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.

Time frame:: Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
Reported as:: Mean · ng/mL

Cmax - Maximum Observed Plasma BIA 2-194 Concentration
ng/mL	Cmax (BIA 2-194)
Day 1	0.00 ± 0.00
Day 2	8443 ± 1422
Day 4	10691 ± 1736
Day 6	10961 ± 1737
Day 8	10175 ± 996
Day 10	10332 ± 1470
Day 12	10821 ± 1806
Day 14	10670 ± 1447
Day 15	9978 ± 1452

SecondaryCmax

Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)

Time frame:: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
Reported as:: Mean · pg/mL

Cmax
pg/mL	Overall Population
Cmax (ethinyloestradiol) Test	53.4 ± 17.9
Cmax (ethinyloestradiol) Reference	66.1 ± 19.1
Cmax (Levonorgestrel) Test	3220 ± 1330
Cmax (Levonorgestrel) Reference	3720 ± 1540

SecondaryTmax

Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)

Time frame:: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
Reported as:: Mean · h

Tmax
h	Overall Population
tmax (ethinyloestradiol) Test	1.67 ± 0.53
tmax (ethinyloestradiol) Reference	1.52 ± 0.21
tmax (Levonorgestrel) Test	1.28 ± 0.49
tmax (Levonorgestrel) Reference	1.21 ± 0.36

SecondaryAUC0-t

AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)

Time frame:: pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.
Reported as:: Mean · pg.h/mL

AUC0-t
pg.h/mL	Overall Population
AUC0-t (ethinyloestradiol) Test	347 ± 145
AUC0-t (ethinyloestradiol) Reference	595 ± 639
AUC0-t (Levonorgestrel) Test	24000 ± 12100
AUC0-t (Levonorgestrel) Reference	33600 ± 20000

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Eslicarbazepine Acetate 1200 mg + Microginon®	—	1/20 (5%)	19/19 (100%)
Microginon®	—	0/20 (0%)	5/18 (27.8%)

Most frequent serious events

Most frequent serious events
Event	Eslicarbazepine Acetate 1200 mg + Microginon®	Microginon®
Abnormal values of neutrophils and white blood cellsInfections and infestations	1/20	0/20

Most frequent other events

Showing 10 of 53

Most frequent other events
Event	Eslicarbazepine Acetate 1200 mg + Microginon®	Microginon®
SomnolenceNervous system disorders	14/19	0/18
DizzinessNervous system disorders	10/19	0/18
ConstipationGastrointestinal disorders	5/19	1/18
NauseaGastrointestinal disorders	5/19	0/18
HeadacheNervous system disorders	4/19	1/18
PalpitationsCardiac disorders	3/19	0/18
Increased thirstGeneral disorders	3/19	0/18
Catheter site ecchymosisInjury, poisoning and procedural complications	3/19	0/18
Paraesthesia lipsNervous system disorders	3/19	0/18
Vasovagal reactionNervous system disorders	2/19	1/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Treatment Sequence A	Treatment Sequence B	Total
<=18 years	0	0	0
Between 18 and 65 years	10	10	20
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment Sequence A	Treatment Sequence B	Total
Female	10	10	20
Male	0	0	0

Study locations

1 site

BIAL - Portela & Cª, S.A.
S. Mamede do Coronado, 4045-457, Portugal

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02281448
Lead sponsor: Bial - Portela C S.A.
Responsible party: Sponsor
First posted: Nov 2, 2014
Start date: Mar 2005
Primary completion: May 2005
Completion: May 2005
Results posted: Dec 3, 2014
Last update: Dec 3, 2014

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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