Contraception
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Society of Family Planning
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Etonogestrel (ENG) Level | Baseline (enrollment) | ENG levels will be measured prior to initiation of isotretinoin therapy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Participants Participants meeting all inclusion/exclusion criteria and enrolled into the study | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Excluded | 40 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Screen fail | 3 |
| Overall Study | Stopped due to drug cost | 1 |
| Overall Study | Stopped due to side effects | 3 |
Baseline characteristics
| Characteristic | Enrolled Participants |
|---|---|
| Age, Continuous | 21 years |
| Body-mass index | 27.4 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Serum Etonogestrel (ENG) Level
ENG levels will be measured prior to initiation of isotretinoin therapy.
Time frame: Baseline (enrollment)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enrolled Participants | Serum Etonogestrel (ENG) Level | 243.3 pg/mL |
Primary
Serum Etonogestrel (ENG) Level
ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy.
Time frame: 4 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enrolled Participants | Serum Etonogestrel (ENG) Level | 234.0 pg/mL |
Primary
Serum Etonogestrel (ENG) Level
ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.
Time frame: 9 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enrolled Participants | Serum Etonogestrel (ENG) Level | 145.4 pg/mL |