Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- breakthrough bleeding on treatment
研究概览
简要总结
Comparison of oral contraceptive pills versus norethindrone to delay menstuation.
详细描述
Many women ask the OBGYN for help in delaying a poorly timed period in order to participate in events that menstruation would normally interfere with. While most OBGYNs prescribe combined oral contraceptives for this purpose, this method often results in unpredictable spotting, especially at the beginning of therapy. Norethindrone, a progesterone agonist, inhibits ovulation through its antagonistic effect at the anterior pituitary, preventing the release of LH. Additionally, it thickens cervical mucus to inhibit sperm migration into the uterine cavity . Norethindrone downregulates estrogen receptors on the endometrium lining preventing endometrial proliferation, enhancing glandular secretion, and maintaining endometrium integrity. Therefore, norethindrone is well suited in preventing the endometrium from breakdown and preventing menstrual bleeding. Indeed, many OBGYNs have consistently used it for this purpose in women who desire to remain fertile. The intention of our study was to compare norethindrone to birth control pills in order to determine the effectiveness at suppressing bleeding and spotting, compare side effect profiles and to find a method allowing women to freely and comfortably participate in their life events.
OBJECTIVES:
- Determine if norethindrone can delay menstruation without breakthrough bleeding
- Compare norethindrone with oral contraceptive pills for delaying menstruation
- Compare patient satisfaction of each method
- Compare side effect profiles of each method
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Patients will be randomized to receive oral contraceptive pills or norethindrone
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
- •female, age 18-45, regular periods, desires to postpone menstrual period,
排除标准
- •fibroids, irregular menstrual cycle, endometrial polyps, BMI>30
研究组 & 干预措施
Norethindrone
Delaying menstruation using Norethindrone 5mg three times daily in women who desire postponement of their period for social or personal reasons.
干预措施: Norethindrone (Drug)
Oral Contraceptive Pills
Women who desire postponing their periods are typically treated with oral contraceptive pills, the current standard of care.
干预措施: oral contraceptive pill (Drug)
结局指标
主要结局
breakthrough bleeding on treatment
时间窗: at 2 weeks from starting therapy
comparison of breakthrough bleeding between oral contraceptives and norethindrone
次要结局
- Likelihood of recommending this method or using it again(at 2 weeks from starting therapty)
- Adverse effects(at 2 weeks from starting therapy)
研究者
Maurice-Andre Recanati
Assistant Professor, Clinical Educator
Wayne State University