Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
problem with recruiting participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles
compare the effects of Zoely® and Minidoz® on hemostatic profiles : D-dimer, Antithrombin and fibrinogen
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoely | Active Comparator | Monophasic combined oral contraceptive pills 24 white active tablets and 4 yellow inactive tablets each active tablet contains 1.5 mg estradiol and 2.5 mg nomegestrol acetate 3 cycles |
|
| Minidoz | Active Comparator | Monophasic combined oral contraceptive pills 24 active tablets and 4 inactive tablets each active tablet contains ethinylestradiol 15 µg and gestodene 60 µg 3 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.5 mg estradiol and 2.5 mg nomegestrol acetate | Drug |
|
| |
| 15 µg ethinylestradiol and 60 µg gestodene |
| Measure | Description | Time Frame |
|---|---|---|
| D-dimer | µg/L | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fibrinogen | mg/dL | 12 weeks |
| antithrombin III | percent | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019851 | Thrombophilia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004958 | Estradiol |
| C038501 | nomegestrol acetate |
| D004997 | Ethinyl Estradiol |
| C033273 | Gestodene |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| to access menstrual cycle and bleeding pattern, side effects of Zoely® and Minidoz® |
| 12 weeks |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D042782 | Estrogenic Steroids, Alkylated |