Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001316-37 | EudraCT Number |
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
Not provided
Not provided
Not provided
Not provided
The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 mg E4/3 mg DRSP | Experimental | 15 mg estetrol/3 mg drospirenone combined oral contraceptive |
|
| 30 mcg EE/150 mcg LNG | Active Comparator | 30 mcg ethinylestradiol/150 mcg levonorgestrel combined oral contraceptive |
|
| 20 mcg EE/3 mg DRSP | Active Comparator | 20 mcg ethinylestradiol/3 mg drospirenone combined oral contraceptive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15 mg E4/3 mg DRSP | Drug | 15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of prothrombin fragment 1+2 | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). | |
| Plasma concentration of APC resistance (ETP-based, APTT-based) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). | |
| Plasma concentration of D-dimer | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). | |
| Plasma concentration of factor VII | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). | |
| Plasma concentration of factor VIII | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). | |
| Plasma concentration of von Willebrand factor | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). | |
| Plasma concentration of factor II | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). | |
| Plasma concentration of antithrombin | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events as a measure of safety and tolerability | From up to 28 days before randomization to maximum Day 4 of the Cycle 7 (1 cycle = 28 days). | |
| Serum concentration of lactate dehydrogenase (LDH) 1 and 2 | Between Days 18 and 21 for the pretreatment Cycle and between Days 18 and 21 for the Cycle 6 (1 cycle = 28 days) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine Klipping | Dinox BV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dinox BV | Groningen | 9713 GZ | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004953 | Estetrol |
| C035144 | drospirenone |
| D004997 | Ethinyl Estradiol |
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D004964 | Estriol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 30 mcg EE/150 mcg LNG | Drug | 30 mcg EE combined with 150 mcg LNG administered in a 21/7-day regimen (i.e. 21 days of yellow active tablets followed by 7 days of white placebo tablets). One tablet per day orally for 6 treatment cycles. |
|
|
| 20 mcg EE/3 mg DRSP | Drug | 20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles. |
|
|
| Plasma concentration of free and total Protein S | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Plasma concentration of protein C | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Plasma concentration of plasminogen activator inhibitor type-1 (PAI-1) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Plasma concentration of tissue type plasminogen activator (t-PA) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Plasma concentration of plasminogen | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Plasma concentration of free tissue factor pathway inhibitor (TPFI) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Plasma concentration of E-selectin | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Plasma concentration of fibrinogen | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of insulin | At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of glucose | At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of C-peptide | At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for Cycles 3 and 6 (1 cycle = 28 days). |
| Plasma concentration of glycated hemoglobin (HbA1c) | At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) | At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Oral glucose tolerance test (OGTT) | At 0 (pre-glucose challenge), 30, 60, 90, 120 and 180 minutes after glucose challenge during pretreatment Cycle; at 0 (pre-glucose challenge), 30, 60, 90, 120 and 180 minutes after glucose challenge during Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of prolactin | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of follicle-stimulating hormone (FSH) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of luteinizing hormone (LH) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of estradiol (E2) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of progesterone (P) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of thyroïd stimulating hormone (TSH) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of free thyroxine (fT3)/free triiodothyronine (fT4) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of dihydroepiandrostenedione (DHEAS) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of androstenedione | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of total testosterone (T) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of dihydrotestosterone (DHT) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of total cortisol | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of aldosterone | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of high density lipoprotein (HDL)-cholesterol | At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of low density lipoprotein (LDL)-cholesterol | At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of total cholesterol | At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of triglycerides | At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of lipoprotein (a) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of apoliporotein A1 | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of apoliporotein B | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of C-reactive protein | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of corticosteroid binding globulin (CBG) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of sex hormone binding globulin (SHBG) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of thyroxin binding globulin (TBG) | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of angiotensinogen | Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days). |
| Serum concentration of tropinin T and I | Between Days 18 and 21 for the pretreatment Cycle and between Days 18 and 21 for the Cycle 6 (1 cycle = 28 days) |
| Electrocardiogram (ECG) parameters | The following ECG parameters will be recorded: heart rate, PR-interval, QRS-duration, QT-interval, QTc interval (Fridericias's) | At screening and between Days 18 and 21 for Cycle 6 (1 cycle = 28 days). |
| Echocardiographic parameters | At screening and between Days 18 and 21 for Cycle 6 (1 cycle = 28 days). |
| Change from baseline to end of treatment in the different items of the menstrual distress questionnaires (MDQ) form C | At pretreatment Cycle and between Days 18 and 21 for Cycle 6 (1 cycle = 28 days). |
| Fused-Ring Compounds |
| 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 |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |