The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
121
Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.
Serum Concentration of Prothrombin Fragments 1 + 2
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of D-Dimer
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (ETP-based) measures the anticoagulation response of plasma to APC after activation of the extrinsic coagulation pathway. An increase in the ratio indicates a reduced responsiveness to APC. Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Clotting Factor VIIa
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Clotting Factor VIIc
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Clotting Factor VIII
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
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Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Clotting Factor II
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Antithrombin III
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Protein S (Free)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Protein S (Total)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Protein C
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). APC resistance ratio (APTT-based) measures the anticoagulation response of plasma to APC after activation of the intrinsic coagulation pathway. An increase in the ratio indicates a increased responsiveness to APC. Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Sex Hormone Binding Globulin (SHBG)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of C-Reactive Protein (CRP)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Total Cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of HDL2-cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of HDL3-cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Apolipoprotein A-1
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Apolipoprotein B
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Lipoprotein(a)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Total Triglycerides
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT])
Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Incremental AUC3 for Glucose (OGTT)
Blood glucose levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3\*fasting concentration. Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
AUC3 for Insulin (OGTT)
Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Incremental AUC3 for Insulin (OGTT)
Blood insulin levels were determined as fasting values just before oral glucose intake and each half hour thereafter for 2 hours and again after 3 hours. Oral glucose tolerance was analysed using the (unadjusted) area under the curve over the 3 hours (AUC3). Incremental area under the curve was defined as incremental AUC3 = AUC3 - 3\*fasting concentration. Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Hemoglobin Type A1c (HbA1c)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). HbA1c was determined before glucose loading. Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Total Cortisol
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Corticosteroid Binding Globulin (CBG)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline to Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Thyroid Stimulating Hormone (TSH)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Free Thyroxine (T4)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Thyroxin Binding Globulin (TBG)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Total Testosterone
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Free Testosterone
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Androstenedione
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Serum Concentration of Dihydrotestosterone (DHT)
Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of 2 days. Each 13 cycles (28 days per cycle) constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
Time frame: 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Time frame: Every 28-day cycle for 5 cycles
Average Number of Breakthrough Bleeding/Spotting Days
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: NOMAC-E2: 21-day period starting on Day 4 of the cycle; LNG-EE: 21-day period starting on Day 1 of the cycle.
Time frame: Every 28-day cycle for 6 cycles
Average Number of Withdrawal Bleeding/Spotting Days
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding/spotting was defined as any episode that occurred during the "expected bleeding period". Expected bleeding period: NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle; LNG-EE: 7-day period starting on Day 22 of the cycle.
Time frame: Every 28-day cycle for 6 cycles