Contraception
Conditions
Brief summary
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.
Interventions
DRUGNOMAC-E2
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.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Sexually active women, at risk for pregnancy and not planning to use during trial medication use; * Women in need for contraception and willing to use an oral contraceptive (OC) for 6 months (6 cycles); * At least 18 but not older than 50 years of age at the time of screening; * Body mass index = 17 and = 29 kg/m\^2; * Good physical and mental health; * Willing to give informed consent in writing
Exclusion criteria
* Present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use); * Contraindications for contraceptive steroids * Presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator. * An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia \[CIN\], SIL, carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months before screening; * Clinically relevant abnormal laboratory result at screening as judged by the (sub) investigator; * Use of an injectable hormonal method of contraception prior to screening; within 6 months of an injection with a 3 -month duration, within 4 months to screening of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration; * Before spontaneous menstruation has occurred following a delivery or abortion; * Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication; * Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, lipid-lowering drugs, anticoagulants and herbal remedies containing Hypericum perforatum (St John's Wort); * Use of pharmacological agents which affect the hemostatic system during the pretreatment blood sampling: vitamin K (only prohibited within two weeks prior to sampling), nonsteroidal anti-inflammatory drugs (NSAIDS) and aspirin (both only prohibited during the week prior to sampling); * Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of Thyroxin Binding Globulin (TBG) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Apolipoprotein A-1 | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Apolipoprotein B | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Lipoprotein(a) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Total Triglycerides | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT]) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | 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. |
| Incremental AUC3 for Glucose (OGTT) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | 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. |
| AUC3 for Insulin (OGTT) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | 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. |
| Incremental AUC3 for Insulin (OGTT) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | 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. |
| Serum Concentration of Hemoglobin Type A1c (HbA1c) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | 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. |
| Serum Concentration of Total Cortisol | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Corticosteroid Binding Globulin (CBG) | Baseline to Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Thyroid Stimulating Hormone (TSH) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Free Thyroxine (T4) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Prothrombin Fragments 1 + 2 | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of D-Dimer | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | 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. |
| Serum Concentration of Clotting Factor VIIa | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Clotting Factor VIIc | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Clotting Factor VIII | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Clotting Factor II | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Antithrombin III | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Protein S (Free) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Protein S (Total) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Protein C | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | 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. |
| Serum Concentration of Sex Hormone Binding Globulin (SHBG) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of C-Reactive Protein (CRP) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Total Cholesterol | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of HDL2-cholesterol | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of HDL3-cholesterol | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of Free Testosterone | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Androstenedione | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Serum Concentration of Dihydrotestosterone (DHT) | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
| Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | 6 cycles | 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. |
| Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Every 28-day cycle for 6 cycles | 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. |
| Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Every 28-day cycle for 6 cycles | 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. |
| Number of Participants With an Occurrence of Breakthrough Bleeding | Every 28-day cycle for 6 cycles | 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. |
| Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Every 28-day cycle for 6 cycles | 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. |
| Number of Participants With an Occurrence of Early Withdrawal Bleeding | Every 28-day cycle for 6 cycles | 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. |
| Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Every 28-day cycle for 5 cycles | 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. |
| Average Number of Breakthrough Bleeding/Spotting Days | Every 28-day cycle for 6 cycles | 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. |
| Average Number of Withdrawal Bleeding/Spotting Days | Every 28-day cycle for 6 cycles | 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. |
| Serum Concentration of Total Testosterone | Baseline and Cycle 6 (between Days 15 and 21 of the cycle) | Serum samples were obtained under fasting conditions (no food or alcoholic beverages within 12 hours of serum sampling). Each cycle consists of 28 days. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NOMAC-E2 All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles | 60 |
| LNG-EE All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg
ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day cycles | 58 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Other Reason | 0 | 1 |
| Overall Study | Other reason pre-treatment | 0 | 1 |
| Overall Study | Pregnancy Wish | 1 | 0 |
| Overall Study | Pre-treatment (serious) adverse event | 0 | 1 |
| Overall Study | Withdrawal of informed consent | 0 | 1 |
Baseline characteristics
| Characteristic | NOMAC-E2 | LNG-EE | Total |
|---|---|---|---|
| Age, Continuous | 28.2 years STANDARD_DEVIATION 8.2 | 29.1 years STANDARD_DEVIATION 7.8 | 28.7 years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 60 Participants | 58 Participants | 118 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 60 | 18 / 58 |
| serious Total, serious adverse events | 1 / 60 | 0 / 58 |
Outcome results
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based) | Baseline (n=59 NOMAC-E2; n=58 LNG-EE) | 0.80 Ratio | Standard Deviation 0.33 |
| NOMAC-E2 | Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 1.14 Ratio | Standard Deviation 0.45 |
| LNG-EE | Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based) | Baseline (n=59 NOMAC-E2; n=58 LNG-EE) | 0.83 Ratio | Standard Deviation 0.4 |
| LNG-EE | Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 1.99 Ratio | Standard Deviation 0.76 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 1.01 Ratio | Standard Deviation 0.13 |
| NOMAC-E2 | APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 1.05 Ratio | Standard Deviation 0.13 |
| LNG-EE | APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 1.00 Ratio | Standard Deviation 0.13 |
| LNG-EE | APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 1.03 Ratio | Standard Deviation 0.12 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.9662Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT]) | Baseline (n=59 NOMAC-E2; n=55 LNG-EE) | 15.82 hrs*mmol/L | Standard Deviation 3.27 |
| NOMAC-E2 | Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT]) | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 16.09 hrs*mmol/L | Standard Deviation 3.05 |
| LNG-EE | Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT]) | Baseline (n=59 NOMAC-E2; n=55 LNG-EE) | 14.44 hrs*mmol/L | Standard Deviation 2.47 |
| LNG-EE | Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT]) | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 16.69 hrs*mmol/L | Standard Deviation 3.15 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0016Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | AUC3 for Insulin (OGTT) | Baseline (n=51 NOMAC-E2; n=50 LNG-EE) | 650 hrs*pmol/L | Standard Deviation 298 |
| NOMAC-E2 | AUC3 for Insulin (OGTT) | Cycle 6 (n=46 NOMAC-E2; n=47 LNG-EE) | 658 hrs*pmol/L | Standard Deviation 281 |
| LNG-EE | AUC3 for Insulin (OGTT) | Baseline (n=51 NOMAC-E2; n=50 LNG-EE) | 558 hrs*pmol/L | Standard Deviation 182 |
| LNG-EE | AUC3 for Insulin (OGTT) | Cycle 6 (n=46 NOMAC-E2; n=47 LNG-EE) | 721 hrs*pmol/L | Standard Deviation 264 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0009Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Incremental AUC3 for Glucose (OGTT) | Baseline (n=59 NOMAC-E2; n=55 LNG-EE) | 1.58 hrs*mmol/L | Standard Deviation 3.05 |
| NOMAC-E2 | Incremental AUC3 for Glucose (OGTT) | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 1.76 hrs*mmol/L | Standard Deviation 2.72 |
| LNG-EE | Incremental AUC3 for Glucose (OGTT) | Baseline (n=59 NOMAC-E2; n=55 LNG-EE) | 1.06 hrs*mmol/L | Standard Deviation 2.55 |
| LNG-EE | Incremental AUC3 for Glucose (OGTT) | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 3.19 hrs*mmol/L | Standard Deviation 3.03 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0003Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Incremental AUC3 for Insulin (OGTT) | Baseline (n=51 NOMAC-E2; n=50 LNG-EE) | 517 hrs*pmol/L | Standard Deviation 268 |
| NOMAC-E2 | Incremental AUC3 for Insulin (OGTT) | Cycle 6 (n=46 NOMAC-E2; n=47 LNG-EE) | 534 hrs*pmol/L | Standard Deviation 239 |
| LNG-EE | Incremental AUC3 for Insulin (OGTT) | Baseline (n=51 NOMAC-E2; n=50 LNG-EE) | 451 hrs*pmol/L | Standard Deviation 160 |
| LNG-EE | Incremental AUC3 for Insulin (OGTT) | Cycle 6 (n=46 NOMAC-E2; n=47 LNG-EE) | 603 hrs*pmol/L | Standard Deviation 237 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0024Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Antithrombin III | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 100 Percent of normal | Standard Deviation 10 |
| NOMAC-E2 | Serum Concentration of Antithrombin III | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 102 Percent of normal | Standard Deviation 9 |
| LNG-EE | Serum Concentration of Antithrombin III | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 99 Percent of normal | Standard Deviation 11 |
| LNG-EE | Serum Concentration of Antithrombin III | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 96 Percent of normal | Standard Deviation 12 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0041Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Apolipoprotein A-1 | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 1.58 g/L | Standard Deviation 0.27 |
| NOMAC-E2 | Serum Concentration of Apolipoprotein A-1 | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 1.78 g/L | Standard Deviation 0.27 |
| LNG-EE | Serum Concentration of Apolipoprotein A-1 | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 1.60 g/L | Standard Deviation 0.25 |
| LNG-EE | Serum Concentration of Apolipoprotein A-1 | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 1.67 g/L | Standard Deviation 0.2 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0063Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Apolipoprotein B | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 0.64 g/L | Standard Deviation 0.17 |
| NOMAC-E2 | Serum Concentration of Apolipoprotein B | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 0.68 g/L | Standard Deviation 0.17 |
| LNG-EE | Serum Concentration of Apolipoprotein B | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 0.64 g/L | Standard Deviation 0.15 |
| LNG-EE | Serum Concentration of Apolipoprotein B | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 0.80 g/L | Standard Deviation 0.21 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Clotting Factor II | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 94 Percent of normal | Standard Deviation 11 |
| NOMAC-E2 | Serum Concentration of Clotting Factor II | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 95 Percent of normal | Standard Deviation 13 |
| LNG-EE | Serum Concentration of Clotting Factor II | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 94 Percent of normal | Standard Deviation 12 |
| LNG-EE | Serum Concentration of Clotting Factor II | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 97 Percent of normal | Standard Deviation 11 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.5027Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Clotting Factor VIIa | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 84 U/L | Standard Deviation 32 |
| NOMAC-E2 | Serum Concentration of Clotting Factor VIIa | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 118 U/L | Standard Deviation 180 |
| LNG-EE | Serum Concentration of Clotting Factor VIIa | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 85 U/L | Standard Deviation 37 |
| LNG-EE | Serum Concentration of Clotting Factor VIIa | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 98 U/L | Standard Deviation 66 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.4191Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Clotting Factor VIIc | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 105 Percent of normal | Standard Deviation 24 |
| NOMAC-E2 | Serum Concentration of Clotting Factor VIIc | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 109 Percent of normal | Standard Deviation 31 |
| LNG-EE | Serum Concentration of Clotting Factor VIIc | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 105 Percent of normal | Standard Deviation 22 |
| LNG-EE | Serum Concentration of Clotting Factor VIIc | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 96 Percent of normal | Standard Deviation 25 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.001Cochran-Mantel-Haenszel
Primary
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.
Time frame: Baseline and Cycle 6 (between Days 15 and 21 of the cycle)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Clotting Factor VIII | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 93 Percent of normal | Standard Deviation 32 |
| NOMAC-E2 | Serum Concentration of Clotting Factor VIII | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 89 Percent of normal | Standard Deviation 34 |
| LNG-EE | Serum Concentration of Clotting Factor VIII | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 95 Percent of normal | Standard Deviation 32 |
| LNG-EE | Serum Concentration of Clotting Factor VIII | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 98 Percent of normal | Standard Deviation 30 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.3779Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Corticosteroid Binding Globulin (CBG) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 910 nmol/L | Standard Deviation 201 |
| NOMAC-E2 | Serum Concentration of Corticosteroid Binding Globulin (CBG) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 1116 nmol/L | Standard Deviation 252 |
| LNG-EE | Serum Concentration of Corticosteroid Binding Globulin (CBG) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 932 nmol/L | Standard Deviation 163 |
| LNG-EE | Serum Concentration of Corticosteroid Binding Globulin (CBG) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 1980 nmol/L | Standard Deviation 389 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of C-Reactive Protein (CRP) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 0.82 mg/L | Standard Deviation 1.16 |
| NOMAC-E2 | Serum Concentration of C-Reactive Protein (CRP) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 1.32 mg/L | Standard Deviation 2.36 |
| LNG-EE | Serum Concentration of C-Reactive Protein (CRP) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 0.98 mg/L | Standard Deviation 1.35 |
| LNG-EE | Serum Concentration of C-Reactive Protein (CRP) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 4.43 mg/L | Standard Deviation 8.43 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of D-Dimer | Baseline (n=60; NOMAC-E2; n=58) | 0.21 mg/L Fibrinogen Equivalent Units (FEU) | Standard Deviation 0.16 |
| NOMAC-E2 | Serum Concentration of D-Dimer | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 0.18 mg/L Fibrinogen Equivalent Units (FEU) | Standard Deviation 0.14 |
| LNG-EE | Serum Concentration of D-Dimer | Baseline (n=60; NOMAC-E2; n=58) | 0.19 mg/L Fibrinogen Equivalent Units (FEU) | Standard Deviation 0.14 |
| LNG-EE | Serum Concentration of D-Dimer | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 0.26 mg/L Fibrinogen Equivalent Units (FEU) | Standard Deviation 0.21 |
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Free Thyroxine (T4) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 14.0 pmol/L | Standard Deviation 1.5 |
| NOMAC-E2 | Serum Concentration of Free Thyroxine (T4) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 15.9 pmol/L | Standard Deviation 2 |
| LNG-EE | Serum Concentration of Free Thyroxine (T4) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 14.1 pmol/L | Standard Deviation 1.5 |
| LNG-EE | Serum Concentration of Free Thyroxine (T4) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 15.7 pmol/L | Standard Deviation 2.1 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.177Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of HDL2-cholesterol | Baseline (n=58 NOMAC-E2; n=50 LNG-EE) | 0.63 mmol/L | Standard Deviation 0.26 |
| NOMAC-E2 | Serum Concentration of HDL2-cholesterol | Cycle 6 (n=52 NOMAC-E2; n=51 LNG-EE) | 0.55 mmol/L | Standard Deviation 0.25 |
| LNG-EE | Serum Concentration of HDL2-cholesterol | Baseline (n=58 NOMAC-E2; n=50 LNG-EE) | 0.69 mmol/L | Standard Deviation 0.29 |
| LNG-EE | Serum Concentration of HDL2-cholesterol | Cycle 6 (n=52 NOMAC-E2; n=51 LNG-EE) | 0.40 mmol/L | Standard Deviation 0.18 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of HDL3-cholesterol | Baseline (n=58 NOMAC-E2; n=50 LNG-EE) | 1.10 mmol/L | Standard Deviation 0.16 |
| NOMAC-E2 | Serum Concentration of HDL3-cholesterol | Cycle 6 (n=52 NOMAC-E2; n=51 LNG-EE) | 1.16 mmol/L | Standard Deviation 0.16 |
| LNG-EE | Serum Concentration of HDL3-cholesterol | Baseline (n=58 NOMAC-E2; n=50 LNG-EE) | 1.14 mmol/L | Standard Deviation 0.19 |
| LNG-EE | Serum Concentration of HDL3-cholesterol | Cycle 6 (n=52 NOMAC-E2; n=51 LNG-EE) | 1.10 mmol/L | Standard Deviation 0.14 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0083Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Hemoglobin Type A1c (HbA1c) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 5.3 Percent of glycosylated hemoglobin | Standard Deviation 0.3 |
| NOMAC-E2 | Serum Concentration of Hemoglobin Type A1c (HbA1c) | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 5.3 Percent of glycosylated hemoglobin | Standard Deviation 0.2 |
| LNG-EE | Serum Concentration of Hemoglobin Type A1c (HbA1c) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 5.3 Percent of glycosylated hemoglobin | Standard Deviation 0.2 |
| LNG-EE | Serum Concentration of Hemoglobin Type A1c (HbA1c) | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 5.4 Percent of glycosylated hemoglobin | Standard Deviation 0.2 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.3653Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 1.63 mmol/L | Standard Deviation 0.36 |
| NOMAC-E2 | Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 1.65 mmol/L | Standard Deviation 0.34 |
| LNG-EE | Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 1.68 mmol/L | Standard Deviation 0.33 |
| LNG-EE | Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 1.41 mmol/L | Standard Deviation 0.26 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Lipoprotein(a) | Baseline (n=60 NOMAC-E2; n=57 LNG-EE) | 0.15 g/L | Standard Deviation 0.18 |
| NOMAC-E2 | Serum Concentration of Lipoprotein(a) | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 0.17 g/L | Standard Deviation 0.22 |
| LNG-EE | Serum Concentration of Lipoprotein(a) | Baseline (n=60 NOMAC-E2; n=57 LNG-EE) | 0.15 g/L | Standard Deviation 0.14 |
| LNG-EE | Serum Concentration of Lipoprotein(a) | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 0.12 g/L | Standard Deviation 0.11 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 2.41 mmol/L | Standard Deviation 0.73 |
| NOMAC-E2 | Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 2.40 mmol/L | Standard Deviation 0.71 |
| LNG-EE | Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 2.47 mmol/L | Standard Deviation 0.66 |
| LNG-EE | Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 2.61 mmol/L | Standard Deviation 0.74 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0455Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Protein C | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 107 Percent of normal | Standard Deviation 18 |
| NOMAC-E2 | Serum Concentration of Protein C | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 108 Percent of normal | Standard Deviation 21 |
| LNG-EE | Serum Concentration of Protein C | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 103 Percent of normal | Standard Deviation 19 |
| LNG-EE | Serum Concentration of Protein C | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 113 Percent of normal | Standard Deviation 20 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0019Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Protein S (Free) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 85 Percent of normal | Standard Deviation 16 |
| NOMAC-E2 | Serum Concentration of Protein S (Free) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 99 Percent of normal | Standard Deviation 20 |
| LNG-EE | Serum Concentration of Protein S (Free) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 86 Percent of normal | Standard Deviation 14 |
| LNG-EE | Serum Concentration of Protein S (Free) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 99 Percent of normal | Standard Deviation 17 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.9662Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Protein S (Total) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 78 Percent of normal | Standard Deviation 12 |
| NOMAC-E2 | Serum Concentration of Protein S (Total) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 83 Percent of normal | Standard Deviation 12 |
| LNG-EE | Serum Concentration of Protein S (Total) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 79 Percent of normal | Standard Deviation 10 |
| LNG-EE | Serum Concentration of Protein S (Total) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 76 Percent of normal | Standard Deviation 9 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0004Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Prothrombin Fragments 1 + 2 | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 0.18 nmol/L | Standard Deviation 0.2 |
| NOMAC-E2 | Serum Concentration of Prothrombin Fragments 1 + 2 | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 0.31 nmol/L | Standard Deviation 1.06 |
| LNG-EE | Serum Concentration of Prothrombin Fragments 1 + 2 | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 0.19 nmol/L | Standard Deviation 0.08 |
| LNG-EE | Serum Concentration of Prothrombin Fragments 1 + 2 | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 0.42 nmol/L | Standard Deviation 1.17 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0849Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Sex Hormone Binding Globulin (SHBG) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 74 nmol/L | Standard Deviation 34 |
| NOMAC-E2 | Serum Concentration of Sex Hormone Binding Globulin (SHBG) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 108 nmol/L | Standard Deviation 44 |
| LNG-EE | Serum Concentration of Sex Hormone Binding Globulin (SHBG) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 77 nmol/L | Standard Deviation 26 |
| LNG-EE | Serum Concentration of Sex Hormone Binding Globulin (SHBG) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 100 nmol/L | Standard Deviation 31 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0187Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Thyroid Stimulating Hormone (TSH) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 2.69 mU/L | Standard Deviation 1.28 |
| NOMAC-E2 | Serum Concentration of Thyroid Stimulating Hormone (TSH) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 2.96 mU/L | Standard Deviation 2.05 |
| LNG-EE | Serum Concentration of Thyroid Stimulating Hormone (TSH) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 2.20 mU/L | Standard Deviation 1.08 |
| LNG-EE | Serum Concentration of Thyroid Stimulating Hormone (TSH) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 2.75 mU/L | Standard Deviation 3.36 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.5668Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Thyroxin Binding Globulin (TBG) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 20.3 mg/L | Standard Deviation 2.9 |
| NOMAC-E2 | Serum Concentration of Thyroxin Binding Globulin (TBG) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 24.2 mg/L | Standard Deviation 3.6 |
| LNG-EE | Serum Concentration of Thyroxin Binding Globulin (TBG) | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 20.3 mg/L | Standard Deviation 3.3 |
| LNG-EE | Serum Concentration of Thyroxin Binding Globulin (TBG) | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 28.4 mg/L | Standard Deviation 5.3 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Total Cholesterol | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 4.48 mmol/L | Standard Deviation 0.87 |
| NOMAC-E2 | Serum Concentration of Total Cholesterol | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 4.51 mmol/L | Standard Deviation 0.83 |
| LNG-EE | Serum Concentration of Total Cholesterol | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 4.53 mmol/L | Standard Deviation 0.82 |
| LNG-EE | Serum Concentration of Total Cholesterol | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 4.48 mmol/L | Standard Deviation 0.75 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.6886Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Total Cortisol | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 482 nmol/L | Standard Deviation 128 |
| NOMAC-E2 | Serum Concentration of Total Cortisol | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 608 nmol/L | Standard Deviation 167 |
| LNG-EE | Serum Concentration of Total Cortisol | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 502 nmol/L | Standard Deviation 153 |
| LNG-EE | Serum Concentration of Total Cortisol | Cycle 6 (n=53 NOMAC-E2; n=52 LNG-EE) | 944 nmol/L | Standard Deviation 183 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: <0.0001Cochran-Mantel-Haenszel
Primary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Total Triglycerides | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 0.94 mmol/L | Standard Deviation 0.3 |
| NOMAC-E2 | Serum Concentration of Total Triglycerides | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 1.00 mmol/L | Standard Deviation 0.37 |
| LNG-EE | Serum Concentration of Total Triglycerides | Baseline (n=60 NOMAC-E2; n=58 LNG-EE) | 0.82 mmol/L | Standard Deviation 0.23 |
| LNG-EE | Serum Concentration of Total Triglycerides | Cycle 6 (n=53 NOMAC-E2; n=51 LNG-EE) | 1.02 mmol/L | Standard Deviation 0.32 |
Comparison: P-value compares the change from baseline to Cycle 6 between treatment groups.p-value: 0.0078Cochran-Mantel-Haenszel
Secondary
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
Population: ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants who had breakthrough bleeding/spotting for the respective cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 1 (n=18 NOMAC-E2; n=16 LNG-EE) | 3.5 Days | Standard Error 2.7 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 2 (n=11 NOMAC-E2; n=9 LNG-EE) | 4.3 Days | Standard Error 1.4 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 3 (n=5 NOMAC-E2; n=5 LNG-EE) | 4.6 Days | Standard Error 2.5 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 4 (n=8 NOMAC-E2; n=2 LNG-EE) | 3.8 Days | Standard Error 2.3 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 5 (n=6 NOMAC-E2; n=4 LNG-EE) | 3.3 Days | Standard Error 2.5 |
| NOMAC-E2 | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 6 (n=6 NOMAC-E2; n=3 LNG-EE) | 4.7 Days | Standard Error 3.7 |
| LNG-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 5 (n=6 NOMAC-E2; n=4 LNG-EE) | 2.0 Days | Standard Error 2 |
| LNG-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 1 (n=18 NOMAC-E2; n=16 LNG-EE) | 4.6 Days | Standard Error 3.6 |
| LNG-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 4 (n=8 NOMAC-E2; n=2 LNG-EE) | 4.0 Days | Standard Error 0 |
| LNG-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 2 (n=11 NOMAC-E2; n=9 LNG-EE) | 3.3 Days | Standard Error 2.2 |
| LNG-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 6 (n=6 NOMAC-E2; n=3 LNG-EE) | 3.0 Days | Standard Error 2 |
| LNG-EE | Average Number of Breakthrough Bleeding/Spotting Days | Cycle 3 (n=5 NOMAC-E2; n=5 LNG-EE) | 3.2 Days | Standard Error 2.2 |
Secondary
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
Population: ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants who had withdrawal bleeding/spotting for the respective cycle.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 1 (n=50 NOMAC-E2; n=53 LNG-EE) | 4.8 Days | Standard Deviation 2.3 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 2 (n=47 NOMAC-E2; n=50 LNG-EE) | 4.7 Days | Standard Deviation 3.6 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 3 (n=49 NOMAC-E2); n=52 LNG-EE) | 3.9 Days | Standard Deviation 2 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 4 (n=46 NOMAC-E2; n=52 LNG-EE) | 4.0 Days | Standard Deviation 2.5 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 5 (n=47 NOMAC-E2; n=51 LNG-EE) | 3.8 Days | Standard Deviation 1.7 |
| NOMAC-E2 | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 6 (n=42 NOMAC-E2; n=49 LNG-EE) | 3.5 Days | Standard Deviation 1.2 |
| LNG-EE | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 5 (n=47 NOMAC-E2; n=51 LNG-EE) | 4.9 Days | Standard Deviation 1.5 |
| LNG-EE | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 1 (n=50 NOMAC-E2; n=53 LNG-EE) | 5.8 Days | Standard Deviation 3.6 |
| LNG-EE | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 4 (n=46 NOMAC-E2; n=52 LNG-EE) | 5.0 Days | Standard Deviation 1.5 |
| LNG-EE | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 2 (n=47 NOMAC-E2; n=50 LNG-EE) | 4.9 Days | Standard Deviation 1.2 |
| LNG-EE | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 6 (n=42 NOMAC-E2; n=49 LNG-EE) | 4.2 Days | Standard Deviation 1.7 |
| LNG-EE | Average Number of Withdrawal Bleeding/Spotting Days | Cycle 3 (n=49 NOMAC-E2); n=52 LNG-EE) | 4.9 Days | Standard Deviation 1.4 |
Secondary
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
Population: The restricted ITT set included all participants treated and excluded nonpregnant participants who didn't have \>=1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse per diary card data).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NOMAC-E2 | Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | 0 Pregnancies per 100 woman years |
| LNG-EE | Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | 0 Pregnancies per 100 woman years |
Secondary
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
Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 6 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 8 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 5 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 8 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 5 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 10 Participants |
| LNG-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 0 Participants |
| LNG-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 0 Participants |
| LNG-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 0 Participants |
| LNG-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 1 Participants |
| LNG-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 1 Participants |
| LNG-EE | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 0 Participants |
Secondary
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
Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 3 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 1 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 1 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 1 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 2 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 3 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 0 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 1 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 0 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 0 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 0 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 0 Participants |
Secondary
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
Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 18 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 11 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 5 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 8 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 6 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 6 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 4 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 16 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 2 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 9 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 3 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 5 Participants |
Secondary
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
Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 17 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 10 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 4 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 7 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 4 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 4 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 4 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 16 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 2 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 9 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 3 Participants |
| LNG-EE | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 5 Participants |
Secondary
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
Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 2 (n=54 NOMAC-E2; n=50 LNG-EE) | 11 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 4 (n=53 NOMAC-E2; n=52 LNG-EE) | 11 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 13 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 13 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 15 Participants |
| LNG-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 29 Participants |
| LNG-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 25 Participants |
| LNG-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 2 (n=54 NOMAC-E2; n=50 LNG-EE) | 28 Participants |
| LNG-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 26 Participants |
| LNG-EE | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Cycle 4 (n=53 NOMAC-E2; n=52 LNG-EE) | 27 Participants |
Secondary
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
Population: The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.~n=number of participants with evaluable cycles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 5 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 4 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 3 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 2 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 1 Participants |
| NOMAC-E2 | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 2 Participants |
| LNG-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 5 (n=52 NOMAC-E2; n=51 LNG-EE) | 0 Participants |
| LNG-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 1 (n=56 NOMAC-E2; n=53 LNG-EE) | 4 Participants |
| LNG-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 4 (n=54 NOMAC-E2; n=52 LNG-EE) | 0 Participants |
| LNG-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 2 (n=55 NOMAC-E2; n=51 LNG-EE) | 1 Participants |
| LNG-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 6 (n=52 NOMAC-E2; n=50 LNG-EE) | 2 Participants |
| LNG-EE | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Cycle 3 (n=54 NOMAC-E2; n=52 LNG-EE) | 1 Participants |
Secondary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Androstenedione | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 9.60 nmol/L | Standard Deviation 3.45 |
| NOMAC-E2 | Serum Concentration of Androstenedione | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 8.23 nmol/L | Standard Deviation 3.01 |
| LNG-EE | Serum Concentration of Androstenedione | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 10.27 nmol/L | Standard Deviation 3.91 |
| LNG-EE | Serum Concentration of Androstenedione | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 6.96 nmol/L | Standard Deviation 3.37 |
Secondary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS) | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 4.94 umol/L | Standard Deviation 2.24 |
| NOMAC-E2 | Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS) | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 4.32 umol/L | Standard Deviation 1.82 |
| LNG-EE | Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS) | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 5.19 umol/L | Standard Deviation 2.26 |
| LNG-EE | Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS) | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 4.00 umol/L | Standard Deviation 1.91 |
Secondary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Dihydrotestosterone (DHT) | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 0.59 nmol/L | Standard Deviation 0.21 |
| NOMAC-E2 | Serum Concentration of Dihydrotestosterone (DHT) | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 0.53 nmol/L | Standard Deviation 0.28 |
| LNG-EE | Serum Concentration of Dihydrotestosterone (DHT) | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 0.62 nmol/L | Standard Deviation 0.26 |
| LNG-EE | Serum Concentration of Dihydrotestosterone (DHT) | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 0.36 nmol/L | Standard Deviation 0.19 |
Secondary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Free Testosterone | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 24.5 pmol/L | Standard Deviation 14.9 |
| NOMAC-E2 | Serum Concentration of Free Testosterone | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 12.8 pmol/L | Standard Deviation 8.8 |
| LNG-EE | Serum Concentration of Free Testosterone | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 26.3 pmol/L | Standard Deviation 16.6 |
| LNG-EE | Serum Concentration of Free Testosterone | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 9.9 pmol/L | Standard Deviation 6.7 |
Secondary
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)
Population: All-participants-treated group; n = number of participants with non-missing baseline value and non-missing change from baseline to Cycle 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOMAC-E2 | Serum Concentration of Total Testosterone | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 1.68 nmol/L | Standard Deviation 0.75 |
| NOMAC-E2 | Serum Concentration of Total Testosterone | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 1.23 nmol/L | Standard Deviation 0.86 |
| LNG-EE | Serum Concentration of Total Testosterone | Baseline (n=60, NOMAC-E2; n=58 LNG-EE) | 1.90 nmol/L | Standard Deviation 0.94 |
| LNG-EE | Serum Concentration of Total Testosterone | Cycle 6 (n=53, NOMAC-E2; n=52 LNG-EE) | 0.91 nmol/L | Standard Deviation 0.57 |