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A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | ITCA 650 20/60 mcg/day, ITCA placebo |
|
| Group 2 | Experimental | ITCA placebo, ITCA 650 20/60 mcg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITCA 650 20/60 mcg/day, ITCA placebo | Drug | ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days, followed by ITCA osmotic mini pump delivering placebo and Levora® for 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve at steady state (AUCss) for ethinyl estradiol and levonorgestrel | from baseline to 13 weeks | |
| Maximum steady state plasma concentration (Cmax,ss) for ethinyl estradiol and levonorgestrel | from baseline to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum steady state plasma concentration (tmax,ss) for ethinyl estradiol and levonorgestrel | Immunogenicity parameters: - ADA (anti-exenatide antibodies) Safety parameters: - Treatment-emergent AEs (TEAEs) including any events local to the placement site, clinical laboratory measurements, ECGs, vital signs and physical examinations. | baseline to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Outcome Measure 1 | Pharmacodynamics - FSH | 13 weeks |
| Additional Outcome Measure 2 | Pharmacodynamics - LH | 13 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS/Miami Research Associates | Miami | Florida | 33143 | United States | ||
| Compass Research |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| ITCA placebo, ITCA 650 20/60 mcg/day | Drug | ITCA osmotic mini pump delivering placebo and Levora® for 28 days, followed by Levora® and ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days |
|
| Apparent plasma clearance at steady-state (CL/Fss) for ethinyl estradiol and levonorgestrel | baseline to 13 weeks |
| Additional Outcome Measure 3 | Pharmacodynamics - progesterone | 13 weeks |
| Orlando |
| Florida |
| 32806 |
| United States |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |