A single center, randomized, open-label, controlled, three-arm study to evaluate the effect of a new combined oral contraceptive (COC) containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and of two reference COCs containing either 30 mcg Ethinylestradiol (EE) and 150 mcg Levonorgestrel (LNG) or 20 mcg EE and 3 mg DRSP on endocrine function, metabolic control and hemostasis during 6 treatment cycles

A single center, randomized, open-label, controlled, three-arm study to evaluate the effect of a new combined oral contraceptive (COC) containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and of two reference COCs containing either 30 mcg Ethinylestradiol (EE) and 150 mcg Levonorgestrel (LNG) or 20 mcg EE and 3 mg DRSP on endocrine function, metabolic control and hemostasis during 6 treatment cycles - E4/DRSP endocrine function, metabolic control and hemostasis study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43221

Enrollment

100

Registered

2016-09-01

Start date

2016-09-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception birth control Contraception

Interventions

The study will start with a screening visit. During the screening visit standard medical assessments including safety laboratory tests (blood draw), a physical examination, ECG and a vital signs mea

Combined oral contraceptive

Endocrine function

Hemostasis

Metabolic control

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age: 18-50 years, inclusive, at time of signing informed consent Body Mass Index: 18.0-30.0 kg/m2, inclusive, at time of screening visit

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

Measure	Time frame
Hemostatic parameters: prothrombin fragment 1+2, activated protein C (APC) resistance (endogenous thrombin potential (ETP)-based, activated partial thromboplastin time (APTT)-based), D-dimer, factor VII, factor VIII, von Willebrand factor, factor II, antithrombin, free and total protein S, protein C, plasminogen activator inhibitor type-1 (PAI-1), tissue plasminogen activator (tPA), plasminogen, free tissue factor pathway inhibitor (TFPI), E-selectin, fibrinogen Endocrine parameters: prolactin, follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), thyroid stimulating hormone (TSH), free thyroxine (fT3)/ free triiodothyronine (fT4), dihydroepiandrostenedione (DHEAS), androstenedione, total testosterone (T), free T, dihydrotestosterone (DHT), total cortisol, and aldosterone Liver proteins: C-reactive protein (CRP), cortisol binding globulin (CBG), sex hormone binding globulin (SHBG), thyroxin binding globulin (TBG) and angiotensinogen Lipid profile: high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, total cholesterol, ratio HDL:LDL cholesterol, lipoprotein (a) [Lp(a)], apolipoprotein A1, apolipoprotein B and triglycerides Glucose metabolism: insulin, glucose, C-peptide, glycated hemoglobin (HbA1c), oral glucose tolerance test (OGTT), homeostasis model assessment-estimated insulin resistance (HOMA-IR).	—

Measure

Time frame

Hemostatic parameters: prothrombin fragment 1+2, activated protein C (APC) resistance (endogenous thrombin potential (ETP)-based, activated partial thromboplastin time (APTT)-based), D-dimer, factor VII, factor VIII, von Willebrand factor, factor II, antithrombin, free and total protein S, protein C, plasminogen activator inhibitor type-1 (PAI-1), tissue plasminogen activator (tPA), plasminogen, free tissue factor pathway inhibitor (TFPI), E-selectin, fibrinogen Endocrine parameters: prolactin, follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), thyroid stimulating hormone (TSH), free thyroxine (fT3)/ free triiodothyronine (fT4), dihydroepiandrostenedione (DHEAS), androstenedione, total testosterone (T), free T, dihydrotestosterone (DHT), total cortisol, and aldosterone Liver proteins: C-reactive protein (CRP), cortisol binding globulin (CBG), sex hormone binding globulin (SHBG), thyroxin binding globulin (TBG) and angiotensinogen Lipid profile: high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, total cholesterol, ratio HDL:LDL cholesterol, lipoprotein (a) [Lp(a)], apolipoprotein A1, apolipoprotein B and triglycerides Glucose metabolism: insulin, glucose, C-peptide, glycated hemoglobin (HbA1c), oral glucose tolerance test (OGTT), homeostasis model assessment-estimated insulin resistance (HOMA-IR).

—

Secondary

Measure	Time frame
Adverse events (AEs), vital signs, physical and gynecological examination, clinical laboratory (including cardiac profile parameters: LDH1, LDH2 and troponin), 12-lead electrocardiogram (ECG), echocardiogram and questionnaire (Menstrual Distress Questionnaire [MDQ] Form C	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)