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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Etonogestrel (ENG) Level | ENG levels will be measured prior to initiation of isotretinoin therapy. | Baseline (enrollment) |
| Serum Etonogestrel (ENG) Level | ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy. | 4 weeks |
| Serum Etonogestrel (ENG) Level | ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy. | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Lazorwitz, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Participants | Participants meeting all inclusion/exclusion criteria and enrolled into the study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Participants | Participants meeting all inclusion/exclusion criteria and enrolled into the study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Etonogestrel (ENG) Level | ENG levels will be measured prior to initiation of isotretinoin therapy. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline (enrollment) |
|
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20 weeks from onset of isotretinoin therapy
Collected primarily any pregnancies
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled Participants | Participants meeting all inclusion/exclusion criteria and enrolled into the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Lazorwitz | University of Colorado Anschutz Medical Campus | 3037242019 | aaron.lazorwitz@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2016 | Jul 6, 2020 | Prot_SAP_000.pdf |
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| Stopped due to side effects |
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| Stopped due to drug cost |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body-mass index | Median | Full Range | kg/m^2 |
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| Primary | Serum Etonogestrel (ENG) Level | ENG levels will be measured 4 weeks after of initiation of isotretinoin therapy. | Posted | Median | Inter-Quartile Range | pg/mL | 4 weeks |
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| Primary | Serum Etonogestrel (ENG) Level | ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy. | Posted | Median | Inter-Quartile Range | pg/mL | 9 weeks |
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| 0 |
| 8 |
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| 8 |
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| 8 |
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