The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.
研究概览
简要总结
The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
详细描述
The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans cell, macrophages, T-lymphocytes and dendritic cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-35 years
- •In general good health
- •With regular menses (every 28-32 days)
- •Seeking contraception and willing to use a hormonal method for at least 6 months
排除标准
- •Current or recent (within the past 8 weeks) vaginitis or pelvic inflammatory disease
- •History of recurrent vaginitis (> 2 episodes in one year, any type)
- •Pregnancy
- •Recent use of hormonal contraceptives
- •Depot medroxyprogesterone: 6 months
- •Progestin implants: 3 months
- •Oral contraceptives: 3 months
- •Hormone impregnated IUD: 3 months
- •Contraindications to use of oral contraceptive pills or vaginal ring
- •History of deep vein thrombosis
- •Known coagulopathy or thrombophilia
- •Unexplained vaginal bleeding
- •Uncontrolled hypertension
- •Diabetes with vascular changes
- •Present or history of hepatic disease or liver tumors
- •Migraines with neurologic changes
- •Myocardial infection
- •Pulmonary embolus
- •Breast cancer
- •Hypersensitivity or allergy to hormonal contraception
- •Heavy Smoking ( ≥ 15 cigarettes per day)
研究组 & 干预措施
Desogen
Drug: ethinyl estradiol and desogestrel
1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days.
Subjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles
干预措施: Desogen (ethinyl estradiol and desogestrel) (Drug)
NuvaRing
Intravaginal Contraception
ethinyl estradiol (0.15 mg/d) and etonogestrel (0.12 mg/d) Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
Subjects had baseline vaginal biopsy followed by 6 cycles of ring use and repeat biopsy at 3 and after 6 cycles
干预措施: NuvaRing (ethinyl estradiol and etonogestrel) (Drug)
结局指标
主要结局
Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.
时间窗: baseline, 84 days, 168 days
Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days
次要结局
- Adverse Events(over 168 days)
研究者
Jeffrey Jensen
MD MPH
Oregon Health and Science University