ContraceptionNCT02967055
The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
An observational study of Contraception, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant. 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
- Contraception
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 30 Jun 2019
- Phase
- Observational
- 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
Study population: Reproductive-aged women (18-45) who are under the care of a dermatologist for treatment of acne and planning to initiate therapy with isotretinoin. The women must have chosen an ENG contraceptive implant for their primary mechanism of birth control, placed at least four weeks prior to study enrollment, but in place no longer than three years.
Who may be able to join
- Have a secondary form of non-hormonal contraception or abstain during isotretinoin therapy and four weeks afterwards
- Have at least two negative pregnancy tests at least 19 days apart prior to initiating isotretinoin therapy
- Have normal baseline laboratory evaluation including liver function tests, basic metabolic panel, and complete blood count
- Willing to abstain from taking any Vitamin A supplement during the study period
- Have a Body Mass Index (BMI) >= 18.5
Who cannot join
- Currently breastfeeding
- Known contraindications to isotretinoin
- Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.
Read the detailed description
The Investigators will enroll only women with an etonogestrel contraceptive implant in place who are initiating isotretinoin therapy through their dermatologist. The Investigators will monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no medications will be provided through this study. No medical devices will be inserted as part of this study either.
- Conditions
- Contraception
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Etonogestrel (ENG) Level
ENG levels will be measured prior to initiation of isotretinoin therapy.
Measured: Baseline (enrollment)
Serum Etonogestrel (ENG) Level
ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.
Measured: 4 weeks
Serum Etonogestrel (ENG) Level
ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start15 Feb 2017
- Primary completion28 Apr 2019
- Study completion30 Jun 2019
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.
- Other trials for ContraceptionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Aaron Lazorwitz, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967055
- Sponsor's protocol ID
- 16-0614
- Status last verified
- Jul 2020
- First submitted
- 14 Nov 2016
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
- ClinicalTrials.gov ID
- NCT02967055
- Acronym / sponsor ID
- 16-0614
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 28 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 11 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.
Detailed description
The Investigators will enroll only women with an etonogestrel contraceptive implant in place who are initiating isotretinoin therapy through their dermatologist. The Investigators will monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no medications will be provided through this study. No medical devices will be inserted as part of this study either.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Reproductive-aged women (18-45) who are under the care of a dermatologist for treatment of acne and planning to initiate therapy with isotretinoin. The women must have chosen an ENG contraceptive implant for their primary mechanism of birth control, placed at least four weeks prior to study enrollment, but in place no longer than three years.
Key inclusion criteria (5 listed)
- Have a secondary form of non-hormonal contraception or abstain during isotretinoin therapy and four weeks afterwards
- Have at least two negative pregnancy tests at least 19 days apart prior to initiating isotretinoin therapy
- Have normal baseline laboratory evaluation including liver function tests, basic metabolic panel, and complete blood count
- Willing to abstain from taking any Vitamin A supplement during the study period
- Have a Body Mass Index (BMI) >= 18.5
Key exclusion criteria (3 listed)
- Currently breastfeeding
- Known contraindications to isotretinoin
- Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Etonogestrel (ENG) Level
Time frame: Baseline (enrollment)
ENG levels will be measured prior to initiation of isotretinoin therapy.
Serum Etonogestrel (ENG) Level
Time frame: 4 weeks
ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.
Serum Etonogestrel (ENG) Level
Time frame: 9 weeks
ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Aaron Lazorwitz, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, 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 5 inclusion and 3 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 11 Aug 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2020). 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 (ENG) Level (time frame: Baseline (enrollment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2020.