MigrainePhase 1NCT03335163
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
A Phase 1 study testing Topiramate in people with Migraine and Migraine;Menstrual, run by University of Colorado, Denver at 1 site in United States.
Trial summary
A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine, Migraine;Menstrual, Contraception
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 22 Apr 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;
- Will maintain their implant during the study without modifications.
Who cannot join
- Women who are taking any medications or supplements known to be
- Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and
- are not willing to abstain from any of these medications or supplements during the entire course of the study.
- Women with liver disease (i.e. hepatitis, fatty liver disease), and
- Women with abnormal liver or renal function, or
- Women with abnormal electrolytes on their screening blood work.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
- Conditions
- Migraine, Migraine;Menstrual, Contraception
- Being tested
- Topiramate
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:
Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| ENG Implant Users | Experimental | Healthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week. Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Etonogestrel Concentrations
The investigators will collect serum from participants at enrollment and at each of the three study follow-up visits. All samples will be batched for analysis. Analysis will be performed using a liquid-chromatography mass-spectrometry validated assay for measurement of serum etonogestrel concentration.
Measured: Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start15 Mar 2018
- Primary completion22 Apr 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum ENG levels in contraceptive implant users
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Stephanie Teal, MD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335163
- Sponsor's protocol ID
- 17-1047
- Status last verified
- Jul 2022
- First submitted
- 3 Nov 2017
- Last updated
- 13 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lazorwitz A, Pena M, Sheeder J, Teal S. Effect of Topiramate on Serum Etonogestrel Concentrations Among Contraceptive Implant Users. Obstet Gynecol. 2022 Apr 1;139(4):579-587. doi: 10.1097/AOG.0000000000004697. Epub 2022 Mar 10.
PubMed 35594123
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
- ClinicalTrials.gov ID
- NCT03335163
- Acronym / sponsor ID
- 17-1047
- Conditions
- Migraine, Migraine;Menstrual, Contraception
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 13 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum Etonogestrel (ENG) levels in contraceptive implant users.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum ENG levels in contraceptive implant users
| Arm | Type | Receives |
|---|---|---|
| ENG Implant Users | Experimental | Drug: TopiramateHealthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;
- Will maintain their implant during the study without modifications.
Key exclusion criteria (6 listed)
- Women who are taking any medications or supplements known to be
- Women with liver disease (i.e. hepatitis, fatty liver disease), and
- Women with abnormal liver or renal function, or
- Women with abnormal electrolytes on their screening blood work.
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 |
|---|---|---|
| TopiramateTopiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day: Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily | Drug | ENG Implant Users |
Primary outcome
Serum Etonogestrel Concentrations
Time frame: Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)
The investigators will collect serum from participants at enrollment and at each of the three study follow-up visits. All samples will be batched for analysis. Analysis will be performed using a liquid-chromatography mass-spectrometry validated assay for measurement of serum etonogestrel concentration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35594123Lazorwitz A, Pena M, Sheeder J, Teal S. Effect of Topiramate on Serum Etonogestrel Concentrations Among Contraceptive Implant Users. Obstet Gynecol. 2022 Apr 1;139(4):579-587. doi: 10.1097/AOG.0000000000004697. Epub 2022 Mar 10.
- Individual participant dataSharing planned: No
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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.
Stephanie Teal, MD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topiramate in people with Migraine and Migraine;Menstrual, run by University of Colorado, Denver at 1 site in United States.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jul 2022. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Etonogestrel Concentrations (time frame: Enrollment (Baseline), 4 weeks (Visit 2), 5 weeks (Visit 3), 6 weeks (Visit 4)). 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 NCT03335163, which also lists 1 linked publication.
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 13 Jul 2022.