Evaluation of the Contraceptive Efficacy, and Safety of Different Types of Progestron Only Pills (Drosperinon 4 mg, Desogestrel 75 pg and Levonorgestrel 30 pg), A Comparative Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Irregular Vaginal Bleeding
研究概览
简要总结
Combined oral contraceptives are not the preparation of first choice in breastfeeding women as they may influence the quality and quantity of breast milk. In these cases, a progestogen-only pill is a suitable alternative, since progestogen-only pills contain no estrogen at all and a much lower dose of progestogen than do combined oral contraceptives
Therefore, progestogen-only pills may also be more acceptable than combined oral contraceptives to women suffering from medical conditions that are associated with the use of combined oral contraceptives (e.g. nausea, headache and breast tension).
详细描述
The most widely prescribed form of hormonal contraception is the combined oral contraceptive, which offers good contraceptive efficacy and a number of non-contraceptive benefits.
However, the combined pill has also been associated with some adverse effects, mainly related to the vascular system, i.e. a slightly higher risk of venous thromboembolic events .
Most studies have linked the risk of venous thromboembolic events dose dependently to the estrogen component. Estrogen-containing oral contraceptives may, therefore, be contraindicated in women with risk factors for venous thromboembolic events.
The current progestogen-only pills contain levonorgestrel, norethisterone, lynestrenol or ethynodiol diacetate have a multifaceted, mode of action .
Ovulation inhibition is achieved in about half of the cycles and contributes only partly to the effectiveness of the method, with effects on the cervical mucus and the endometrium, thus providing additional contraceptive reliability .
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
- None
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18 - 45 years.
- •Non obese women with BMI between 18.5 : 29.9 kg/m
- •Healthy women with good physical and mental health.
- •Sexually active.
- •Women have normal cycles (regular interval, duration, and amount of bleeding.
- •Women willing to accurately fill in the diary card with daily information on vaginal bleeding and pill intake
- •Women willing to give written informed consent.
排除标准
- •obese medical history
- •Contraindications to the use of progesterone only pills with medical eligibility criteria mec category 3 or 4: (malabsorptive procedures, current or history of ischemic heart disease, history of cerebrovascular accident, systemic lupus erythematosus, breast cancer, cirrhosis, liver tumors or antimicrobial therapy).
- •Women with allergy from study medications.
- •Women refusing to participate in the study.
研究组 & 干预措施
Group A: Drospirenon (drospinetta)
About 100 women took Drospirenon (drospinetta) tab every day 24 and 4 placipo tablets for four days
干预措施: Drospinetta (Drug)
Group B: Desogestrel (Cirazette)
About 100 women took Desogestrel (Cirazette) tablet every day
干预措施: Drospinetta (Drug)
Group C: Levonorgestrel (Microlute)
About 100 women took Levonorgestrel (Microlute) tablet every day
干预措施: Drospinetta (Drug)
结局指标
主要结局
Irregular Vaginal Bleeding
时间窗: 9 Months
Efficacy of the different types of the progesterone only pills as : (Drosperinon tablets, Desogestrel tablets and Levonorgestrel tablets) which will be initiated on the first day of menstruation in controlling of irregular vaginal bleeding during menses
次要结局
未报告次要终点
研究者
Heba Tullah Mohamed Alsyed
Resident of Obstetrics & Gynecology
Azhar University