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This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 28-day Desogestrel Oral Contraceptive | Experimental |
| |
| 28-day Drospirenone Oral Contraceptive | Active Comparator |
| |
| 28-day Levonorgestrel Oral Contraceptive | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desogestrel/ethinyl estradiol and ethinyl estradiol | Drug | Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. | 16 weeks | |
| Change in serum Estradiol level from baseline to week 16. | 16 weeks | |
| Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16. | 16 weeks | |
| Change in serum Progesterone level from baseline to week 20. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels. | 15 weeks | |
| Change from baseline to week 15 in D-dimer. | 15 weeks | |
| Change from baseline to end of week 15 in Plasmin-Antiplasmin complex |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teva Women's Health Research Protocol Chair | Teva Branded Pharmaceutical Products R&D, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 10119 | Philadelphia | Pennsylvania | 19114 | United States | ||
| Teva Investigational Site 10118 |
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| 28-day drospirenone oral contraceptive | Drug | Drospirenone/ethinyl estradiol 0.3/0.02 mg |
|
| 28-day levonorgestrel oral contraceptive | Drug | Levonorgestrel/ethinyl estradiol 0.1/0.02 mg |
|
| 15 weeks |
| Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC). | 15 weeks |
| Change from baseline to week 15 in Fibrinogen. | 15 weeks |
| Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S. | 15 weeks |
| Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA). | 15 weeks |
| Change from baseline to week 15 in Antithrombin. | 15 weeks |
| Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI). | 15 weeks |
| Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG). | 15 weeks |
| Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH). | 15 weeks |
| Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG). | 15 weeks |
| Return to ovulation rate at week 20. | Week 20 |
| Seattle |
| Washington |
| 98105 |
| United States |
| ID | Term |
|---|---|
| D017135 | Desogestrel |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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