Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Endometrial Matrix Metalloproteinase Expression by Gel Densitometry
研究概览
简要总结
The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose doxycycline on the irregular bleeding women experience when taking continuous oral contraceptive pills. This research is being done because currently, there is no effective treatment for this condition. Findings from this study could help to decrease the side effects of birth control pills and decrease unplanned pregnancies.
详细描述
Continuous oral contraceptive administration entails women taking hormonally active pills for 28 days without a seven day placebo week to avoid hormonal withdrawal bleeding. Unfortunately, with continuous administration, timed, regular bleeding can be replace by irregular, unscheduled bleeding, which often leads to dissatisfaction, discontinuation and the possibility of unplanned pregnancy.
Matrix Metalloproteinases, a group of zinc-dependant proteases, are hypothesized to play a role in endometrial degradation. The purpose of this study is to describe the expression of Matrix Metalloproteinases in endometrial biopsy specimens collected 1) prior to initiating oral contraceptives 2) while taking cyclic oral contraceptive 3) while taking continuous oral contraceptives and 4) while taking continuous oral contraceptives along with sub-antimicrobial doxycycline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages 18 and 45 who are ovulatory as demonstrated by a pre-treatment Progesterone (P) greater than or equal to 3.0 ng/mL prior to oral contraceptive use
排除标准
- •Women with any absolute contraindications to ethinyl estradiol and levonorgestrel;
- •Women who are pregnant or breastfeeding
- •Use of oral contraceptives, patch, ring, intrauterine or implantable hormonal contraception within 4-weeks;
- •Medroxyprogesterone acetate use within six months;
- •Current use of drugs that interfere with sex steroid metabolism.
研究组 & 干预措施
Sub-antimicrobial doxycycline
Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.
干预措施: Doxycycline (Drug)
结局指标
主要结局
Endometrial Matrix Metalloproteinase Expression by Gel Densitometry
时间窗: 49 days
Baseline Matrix Metalloproteinase expression (activity level) will be determined on day 19-21 of cycle 1. During cycle 2, when women are taking the cyclic oral contraceptive, the endometrial biopsy will be performed between cycle day 19-21 (study day 47-49), prior to endometrial degradation and activity level will be noted. Of note, the outcome is MMP activity level, not a change in level.
次要结局
- Matrix Metalloproteinase Expression and Activity by Gel Densitometry(84 days)
研究者
Bliss Kaneshiro
Assistant Professor
University of Hawaii