A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate the Effects on Hemostasis, Lipids and Carbohydrate Metabolism, and on Adrenal and Thyroid Function of a Monophasic COC Containing 2.5 mg NOMAC and 1.5 mg E2 Compared to a Monophasic COC Containing 150 ug LNG and 30 ug EE
概览
- 阶段
- 3 期
- 干预措施
- NOMAC-E2
- 疾病 / 适应症
- Contraception
- 发起方
- Organon and Co
- 入组人数
- 121
- 主要终点
- Serum Concentration of Clotting Factor VIII
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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);
研究组 & 干预措施
NOMAC-E2
Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive
干预措施: NOMAC-E2
LNG-EE
Levonorgestrel and Ethinyl Estradiol Tablets (LNG-EE), 150 mcg LNG and 30 mcg EE
干预措施: Levonorgestrel and Ethinyl Estradiol
结局指标
主要结局
Serum Concentration of Clotting Factor VIII
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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 Sex Hormone Binding Globulin (SHBG)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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 Total Cholesterol
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
Incremental AUC3 for Glucose (OGTT)
时间窗: 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.
Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT])
时间窗: 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.
AUC3 for Insulin (OGTT)
时间窗: 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.
Serum Concentration of Total Cortisol
时间窗: 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 Thyroid Stimulating Hormone (TSH)
时间窗: 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)
时间窗: 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.
Incremental AUC3 for Insulin (OGTT)
时间窗: 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)
时间窗: 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 Thyroxin Binding Globulin (TBG)
时间窗: 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.
次要结局
- Serum Concentration of Total Testosterone(Baseline and Cycle 6 (between Days 15 and 21 of the cycle))
- Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS)(Baseline and Cycle 6 (between Days 15 and 21 of the cycle))
- Serum Concentration of Androstenedione(Baseline and Cycle 6 (between Days 15 and 21 of the cycle))
- Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)(6 cycles)
- Number of Participants With an Occurrence of Absence of Withdrawal Bleeding(Every 28-day cycle for 6 cycles)
- Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)(Every 28-day cycle for 6 cycles)
- Number of Participants With an Occurrence of Continued Withdrawal Bleeding(Every 28-day cycle for 5 cycles)
- Serum Concentration of Free Testosterone(Baseline and Cycle 6 (between Days 15 and 21 of the cycle))
- Serum Concentration of Dihydrotestosterone (DHT)(Baseline and Cycle 6 (between Days 15 and 21 of the cycle))
- Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting(Every 28-day cycle for 6 cycles)
- Number of Participants With an Occurrence of Breakthrough Bleeding(Every 28-day cycle for 6 cycles)
- Number of Participants With an Occurrence of Early Withdrawal Bleeding(Every 28-day cycle for 6 cycles)
- Average Number of Breakthrough Bleeding/Spotting Days(Every 28-day cycle for 6 cycles)
- Average Number of Withdrawal Bleeding/Spotting Days(Every 28-day cycle for 6 cycles)