N/A
N=54
The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02967055 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Serum Etonogestrel (ENG) Level — 243.3 pg/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Etonogestrel (ENG) Level |
145.4 | — |
| PRIMARY Serum Etonogestrel (ENG) Level |
145.4 | — |
| PRIMARY Serum Etonogestrel (ENG) Level |
145.4 | — |
Summary
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Currently breastfeeding
- Known contraindications to isotretinoin
- Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors
Data sourced from ClinicalTrials.gov (NCT02967055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.