ContraceptionPhase 4NCT03307863

Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy

A Phase 4 study testing Carbamazepine-Implant, Topiramate-Implant and Implant in people with Contraception and Drug Interactions, run by University of Sao Paulo at 1 site in Brazil.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

Search all trials

Trial summary

Data on the interaction between the etonogestrel (ENG) implant and antiepileptic drug (AED) regimen are scarce. We will evaluated the effect of 2 AED regimens (1 including carbamazepine and the other topiramate) on the pharmacokinetic (PK) parameters of an ENG-releasing implant in women with epilepsy. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception, Drug Interactions
What is being tested?: Carbamazepine-Implant, Topiramate-Implant and Implant
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteBrazil
Study dates: 1 Nov 2017to 30 Nov 2028
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

women 18- 45 years old;
with regular menstrual cycles;
with BMI between 18 and 29.9 (kg/m2);
who has selected the ENG implant as a contraceptive method;
Using a stable antiepileptic drug regimen including carbamazepine or topiramate for ate least 3 months (only for women with epilepsy).

Who cannot join

use of short-acting hormonal contraceptives in the month prior to enrollment;
use of depomedroxyprogesterone acetate in the 6 months prior to enrollment;
women with conditions classified as category 3 and/or 4 for etonogestrel implant use according to the World Health Organization Medical Eligibility Criteria for contraceptive use;
drug or alcohol addiction;
use of other drugs metabolized by CYP3A4 30 days prior to enrollment;
non adherence to antiepileptic drug regimen (only for women with epilepsy);
illiteracy

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital das Clínicas de Ribeirão Preto da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14049-900

Other trials in Brazil

About this study

Conditions: Contraception, Drug Interactions
Being tested: Carbamazepine-Implant, Topiramate-Implant, Implant
Keywords: etonogestrel implant, anti-epileptic drugs, pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carbamazepine-ImplantDrug
Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
Topiramate-ImplantDrug
Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
ImplantDrug
Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted

Study groups in NCT03307863
Study group	Role	What they receive
Carbamazepine-Implant	Experimental	Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted Receives: Drug: Carbamazepine-Implant
Topiramate-Implant	Experimental	Women with epilepsy using topiramate for at least 3 months will have an etonogestrel-releasing implant inserted Receives: Drug: Topiramate-Implant
Implant	Active comparator	Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted Receives: Drug: Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for area under the curve evaluation of ENG (AUC, 0-24 weeks). The plasma ENG AUC will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Measured: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using carbamazepine
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmax of ENG. The plasma ENG Cmax will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Measured: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using carbamazepine
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmin of ENG. The plasma ENG Cmin will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Measured: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using carbamazepine
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of Tmax of ENG. The Tmax of ENG will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Measured: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement

Secondary outcomes (13)

Bleeding pattern associated with etonogestrel implant use
Bleeding pattern (frequency, duration and number of bleeding/spotting days) associated with etonogestrel implant use will be evaluated in WWE using carbamazepine or topiramate and in women without epilepsy and without antiepileptic drug use
Measured: Daily for 24 weeks
Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using topiramate
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for area under the curve evaluation of ENG (AUC, 0-24 weeks). The plasma ENG AUC will be compared to that of women without epilepsy and without topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Measured: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using topiramate
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmax of ENG. The plasma ENG Cmax will be compared to that of women without epilepsy and without topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Measured: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using topiramate
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmin of ENG. The plasma ENG Cmin will be compared to that of women without epilepsy and without topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Measured: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using topiramate
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of Tmax of ENG. The Tmax of ENG will be compared to that of women without epilepsy and without topiramate use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Measured: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Area under the plasma concentration versus time curve (AUC) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of carbamazepine
Measured: Prior to implant placement and at 24 weeks of implant use
Plasma maximum concentration (Cmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of carbamazepine
Measured: Prior to implant placement and at 24 weeks of implant use
Plasma minimum concentration (Cmin) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of carbamazepine
Measured: Prior to implant placement and at 24 weeks of implant use
Time to maximum concentration (Tmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of carbamazepine
Measured: Prior to implant placement and at 24 weeks of implant use
Area under the plasma concentration versus time curve (AUC) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate AUC (0-8 hours) of topiramate
Measured: Prior to implant placement and at 24 weeks of implant use
Plasma maximum concentration (Cmax) of topiramate in women with epilepsy (WWE)
Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmax of topiramate
Measured: Prior to implant placement and at 24 weeks of implant use
Plasma minimum concentration (Cmin) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Cmin of topiramate
Measured: Prior to implant placement and at 24 weeks of implant use
Time to maximum concentration (Tmax) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
Blood will be collected prior to etonogestrel implant use and at 24 weeks of its placement to evaluate Tmax of topiramate
Measured: Prior to implant placement and at 24 weeks of implant use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201730 Nov 2028

First posted12 Oct 2017
Study start1 Nov 2017
Primary completion30 Nov 2027 (estimated)
Study completion30 Nov 2028 (estimated)

Why it stopped: We suspended the study for budget issues. It might be resumed in the future.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ContraceptionStudies of the same condition, open and under way.
More trials run by University of Sao PauloThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: It is a non-randomized clinical trial (controlled clinical trial)
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 69 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03307863
Sponsor's protocol ID: 2.140.103
Status last verified: Jan 2025
First submitted: 27 Sep 2017
Last updated: 28 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms

All Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
ClinicalTrials.gov ID: NCT03307863
Acronym / sponsor ID: 2.140.103
Conditions: Contraception, Drug Interactions
Keywords: etonogestrel implant, anti-epileptic drugs, pharmacokinetics
Phase: Phase 4
Study type: Interventional
Recruitment status: SuspendedReason stopped: We suspended the study for budget issues. It might be resumed in the future.
Enrolment: 69 participants (estimated)
Lead sponsor: University of Sao PauloUniversity, hospital or other
Study start: 1 Nov 2017 (actual)
Primary completion: 30 Nov 2027 (estimated)
Study completion: 30 Nov 2028 (estimated)
First posted: 12 Oct 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: It is a non-randomized clinical trial (controlled clinical trial)

Arm	Type	Receives
Carbamazepine-Implant	Experimental	Drug: Carbamazepine-ImplantWomen with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
Topiramate-Implant	Experimental	Drug: Topiramate-ImplantWomen with epilepsy using topiramate for at least 3 months will have an etonogestrel-releasing implant inserted
Implant	Active comparator	Drug: ImplantWomen without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

women 18- 45 years old;
with regular menstrual cycles;
with BMI between 18 and 29.9 (kg/m2);
who has selected the ENG implant as a contraceptive method;
Using a stable antiepileptic drug regimen including carbamazepine or topiramate for ate least 3 months (only for women with epilepsy).

Key exclusion criteria (7 listed)

use of short-acting hormonal contraceptives in the month prior to enrollment;
use of depomedroxyprogesterone acetate in the 6 months prior to enrollment;
women with conditions classified as category 3 and/or 4 for etonogestrel implant use according to the World Health Organization Medical Eligibility Criteria for contraceptive use;
drug or alcohol addiction;
use of other drugs metabolized by CYP3A4 30 days prior to enrollment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Carbamazepine-ImplantWomen with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted	Drug	Carbamazepine-Implant
Topiramate-ImplantWomen with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted	Drug	Topiramate-Implant
ImplantWomen without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted	Drug	Implant

Primary outcome

Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine
Time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for area under the curve evaluation of ENG (AUC, 0-24 weeks). The plasma ENG AUC will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using carbamazepine
Time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmax of ENG. The plasma ENG Cmax will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using carbamazepine
Time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of plasma Cmin of ENG. The plasma ENG Cmin will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.
Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using carbamazepine
Time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Blood will be collected prior to ENG implant insertion and each 15 days for 24 weeks after implant placement for evaluation of Tmax of ENG. The Tmax of ENG will be compared to that of women without epilepsy and without carbamazepine use prior to ENG implant insertion and each 15 days for 24 weeks after implant placement.

13 secondary outcomes

Bleeding pattern associated with etonogestrel implant use
Time frame: Daily for 24 weeks
Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using topiramate
Time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Plasma maximum concentration (Cmax) of ENG in women with epilepsy (WWE) using topiramate
Time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Plasma minimum concentration (Cmin) of ENG in women with epilepsy (WWE) using topiramate
Time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Time to maximum concentration (Tmax) of ENG in women with epilepsy (WWE) using topiramate
Time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement
Area under the plasma concentration versus time curve (AUC) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
Time frame: Prior to implant placement and at 24 weeks of implant use
Plasma maximum concentration (Cmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
Time frame: Prior to implant placement and at 24 weeks of implant use
Plasma minimum concentration (Cmin) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
Time frame: Prior to implant placement and at 24 weeks of implant use
Time to maximum concentration (Tmax) of carbamazepine in women with epilepsy (WWE) before and after ENG implant placement
Time frame: Prior to implant placement and at 24 weeks of implant use
Area under the plasma concentration versus time curve (AUC) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
Time frame: Prior to implant placement and at 24 weeks of implant use
Plasma maximum concentration (Cmax) of topiramate in women with epilepsy (WWE)
Time frame: Prior to implant placement and at 24 weeks of implant use
Plasma minimum concentration (Cmin) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
Time frame: Prior to implant placement and at 24 weeks of implant use
Time to maximum concentration (Tmax) of topiramate in women with epilepsy (WWE) before and after ENG implant placement
Time frame: Prior to implant placement and at 24 weeks of implant use

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.

Related trials for Contraception

Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carolina S Vieira, MD principal investigator

University of Sao Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Carbamazepine-Implant, Topiramate-Implant and Implant in people with Contraception and Drug Interactions, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the plasma concentration versus time curve (AUC) of ENG in women with epilepsy (WWE) using carbamazepine (time frame: Prior to etonogestrel implant insertion and each 15 days for 24 weeks after implant placement). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03307863.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.