Comparison of Oral and Patch Forms of Hormonal Contraception on Plasma Lipoproteins, Glycemia, Clotting Factors, Indices of Inflammation and Vascular Reactivity
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Glucose, insulin, lipoproteins, clotting factors, hormone levels and sex hormone binding globulin
研究概览
简要总结
The purpose of this study is to compare the effects of oral versus patch administration of hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins originating from the liver while patch administration of contraceptive hormones will result in greater systemic effects of estrogen on vascular reactivity and antioxidant status.
详细描述
Study Rationale:
The metabolic effects of hormonal contraceptives differ when administered by oral or systemic routes. The oral route magnifies the hepatic production of hormone sensitive proteins including lipoproteins, clotting factors and inflammatory proteins such as CRP. These effects are due to the first pass of hormone to the liver from the portal circulation. The first pass hepatic effect also reduces the systemic exposure to orally administered estrogen and progestin, due to glucuronidation and sulfation of sex hormones and excretion in the bile. Systemic administration by the patch is more analogous to physiologic hormone release from the ovary, as it avoids the first pass effect and the peripheral tissues are exposed to higher hormone concentrations than with oral administration. Conversely, the liver may have a lower exposure to hormone by patch administration than by oral administration.
With respect to the extended cycle (2-month) patch contraception formulation under study, similar questions may be asked about the metabolic, inflammatory and vascular effects of this regimen compared to the one-month cycles.
The purpose of this research is:
- to measure the plasma estrogen and progestin levels observed with each formulation and the physiological parameters that affect vascular health including lipids, glucose and insulin, redox state, clotting and inflammatory factors, and vascular reactivity; and
- to study the relationships of hormones to physiological parameters among the three regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing to participate in a crossover design study with biweekly or weekly clinic visits in the second, fourth and sixth months.
- •Healthy women within the age range of 18 to 50 years inclusive who are sexually active and at risk for pregnancy.
排除标准
- •Blood pressure above 140/90 mmHg
- •Glucose greater than 126 mg/dL or diabetes mellitus
- •Triglyceride greater than 300 mg/dL
- •Body mass index (BMI) greater than 30 kg/m2 or greater than 18.5 kg/m2
- •Current or past history of thrombophlebitis, deep vein thrombosis or thromboembolic disorders.
- •Current or past history of cerebrovascular or coronary artery disease.
- •Presence of valvular heart disease with complications.
- •Major surgery with prolonged immobilization.
- •Known or suspected carcinoma of the breast or personal history of breast cancer.
- •Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
- •Undiagnosed abnormal genital bleeding.
- •History of cholestatic jaundice during pregnancy or history of jaundice with prior hormonal contraceptive use.
- •Acute or chronic hepatocellular disease with abnormal liver function. Hepatic adenomas or carcinomas.
- •Any active liver or renal disease.
- •Untreated thyroid disease.
- •Migraine or headaches with focal neurological symptoms.
- •Known or suspected pregnancy or currently breast feeding.
- •Alcohol intake above one drink per day
- •Cigarette smoking
- •Depression or any psychiatric illness
- •Any lipid lowering or blood pressure lowering medication
- •Any illegal drug use
- •Non-steroidal anti-inflammatory drug (NSAID) or aspirin use for 5 days prior to vascular reactivity studies.
- •Antioxidant supplements (stable multivitamin use allowed)
- •History of sensitivity or allergic reaction to any hormonal contraceptives.
- •Unwilling or unable to comply with the study protocol
研究组 & 干预措施
Group 1
Visits 2-6: Ortho Evra (R) Visits 6-11: Ortho Cyclen (R) Visits 11-15: extended use of Ortho Evra (R)
干预措施: Ortho-Cyclen (R) (Drug)
Group 1
Visits 2-6: Ortho Evra (R) Visits 6-11: Ortho Cyclen (R) Visits 11-15: extended use of Ortho Evra (R)
干预措施: Ortho Evra (R) (Drug)
Group 1
Visits 2-6: Ortho Evra (R) Visits 6-11: Ortho Cyclen (R) Visits 11-15: extended use of Ortho Evra (R)
干预措施: extended use of Ortho Evra (R) (Drug)
Group 2
Visits 2-6: Ortho Evra (R) Visits 6-11: extended use Ortho Evra (R) Visits 11-15: Ortho Cyclen (R)
干预措施: Ortho-Cyclen (R) (Drug)
Group 2
Visits 2-6: Ortho Evra (R) Visits 6-11: extended use Ortho Evra (R) Visits 11-15: Ortho Cyclen (R)
干预措施: Ortho Evra (R) (Drug)
Group 2
Visits 2-6: Ortho Evra (R) Visits 6-11: extended use Ortho Evra (R) Visits 11-15: Ortho Cyclen (R)
干预措施: extended use of Ortho Evra (R) (Drug)
Group 3
Visits 2-6: Ortho Cyclen (R) Visits 6-11: Ortho Evra (R) Visits 11-15: extended use of Ortho Evra (R)
干预措施: Ortho-Cyclen (R) (Drug)
Group 3
Visits 2-6: Ortho Cyclen (R) Visits 6-11: Ortho Evra (R) Visits 11-15: extended use of Ortho Evra (R)
干预措施: Ortho Evra (R) (Drug)
Group 3
Visits 2-6: Ortho Cyclen (R) Visits 6-11: Ortho Evra (R) Visits 11-15: extended use of Ortho Evra (R)
干预措施: extended use of Ortho Evra (R) (Drug)
Group 4
Visits 2-6: Ortho Cyclen (R) Visits 6-11: extended use of Ortho Evra (R) Visits 11-15: Ortho Evra (R)
干预措施: Ortho-Cyclen (R) (Drug)
Group 4
Visits 2-6: Ortho Cyclen (R) Visits 6-11: extended use of Ortho Evra (R) Visits 11-15: Ortho Evra (R)
干预措施: Ortho Evra (R) (Drug)
Group 4
Visits 2-6: Ortho Cyclen (R) Visits 6-11: extended use of Ortho Evra (R) Visits 11-15: Ortho Evra (R)
干预措施: extended use of Ortho Evra (R) (Drug)
Group 5
Visits 2-6: extended use of Ortho Evra (R) Visits 6-11: Ortho Evra (R) Visits 11-15: Ortho Cyclen (R)
干预措施: Ortho-Cyclen (R) (Drug)
Group 5
Visits 2-6: extended use of Ortho Evra (R) Visits 6-11: Ortho Evra (R) Visits 11-15: Ortho Cyclen (R)
干预措施: Ortho Evra (R) (Drug)
Group 5
Visits 2-6: extended use of Ortho Evra (R) Visits 6-11: Ortho Evra (R) Visits 11-15: Ortho Cyclen (R)
干预措施: extended use of Ortho Evra (R) (Drug)
Group 6
Visits 2-6: extended use of Ortho Evra (R) Visits 6-11: Ortho Cyclen (R) Visits 11-15: Ortho Evra (R)
干预措施: Ortho-Cyclen (R) (Drug)
Group 6
Visits 2-6: extended use of Ortho Evra (R) Visits 6-11: Ortho Cyclen (R) Visits 11-15: Ortho Evra (R)
干预措施: Ortho Evra (R) (Drug)
Group 6
Visits 2-6: extended use of Ortho Evra (R) Visits 6-11: Ortho Cyclen (R) Visits 11-15: Ortho Evra (R)
干预措施: extended use of Ortho Evra (R) (Drug)
结局指标
主要结局
Glucose, insulin, lipoproteins, clotting factors, hormone levels and sex hormone binding globulin
时间窗: measured at baseline and days 1, 7, 21 and 28 of study months 2, 4 and 6
inflammatory proteins, apoproteins and total antioxidant capacity
时间窗: measured at baseline and days 1 and 21 of study months 2, 4 and 6
vascular reactivity
时间窗: measured at baseline and day 21 of study months 2, 4 and 6
次要结局
未报告次要终点