Are the Combined Oral Contraceptive Pills Needed for Management of the Simple Ovarian Cysts in Reproductive Women? (Randomized Controlled Study)
试验速览
- 阶段
- 2 期
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Remission
研究概览
简要总结
Women will be managed by either of the two modalities and will be followed up by transvaginal ultrasound monthly for three successive months to evaluate the size and location of the functional ovarian cyst (follicular), to compare the effect of different modalities of management whether remission, regression, progression or persistence of functional ovarian cyst.
The women will be assigned randomly to either study group to take oral contraceptive pills or to control group to take placebo. The 2 groups will be treated and followed up equally. Oral contraceptive pills will be given to the study group as follow:
The women will receive one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram) and will be counseled about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. All results of the two groups will be compared. Data will be collected, tabulated according to the standard statistical method.
详细描述
Women will be managed by either of the two modalities and will be followed up by transvaginal ultrasound monthly for three successive months to evaluate the size and location of the functional ovarian cyst (follicular), to compare the effect of different modalities of management whether remission, regression, progression or persistence of functional ovarian cyst.
The women will be assigned randomly to either study group to take oral contraceptive pills or to control group to take placebo. The 2 groups will be treated and followed up equally. Oral contraceptive pills will be given to the study group as follow:
The women will receive one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram) and will be counseled about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month. All results of the two groups will be compared. Data will be collected, tabulated according to the standard statistical method.
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
- Double (Participant, Care Provider)
盲法说明
Both trial participants and research coordinator will be blinded about the treatment after assignment. Oral contraceptive pills and placebo will be put in 2 packages with different colors and only the main researcher will know the type of treatment used for each group. Unbinding is only permissible, if sever morbidity or even mortality occur to any participants.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •include women in reproductive age ovarian cysts unilateral, 2.5-6 centimeters in diameter, thin wall, unilocular without internal echoes and no solid parts.
排除标准
- •Exclusion criteria include premenarche, post menopause and neoplastic ovarian swelling (any swelling more than 6cm or multilocular).
研究组 & 干预措施
no intervention
The women will receive one package of placebo. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month.
干预措施: combined oral contraceptive pills (Drug)
combined oral contraception pills
The women will receive intervention of one package of combined oral contraception pills and will be counseled about how to take oral contraception and informed of possible side effects. They also will receive a diary card for recording oral contraception intake to be returned to the physician on the next period. An appointment for the women in this group will be scheduled at one month of treatment for the second ultra-sonography. If the ovarian cyst does not show remission, the women will continue the same treatment and will follow up in another month by transvaginal ultra-sound. If the ovarian cyst still persists or progresses at the second month, the women will be followed up for third month.
干预措施: combined oral contraceptive pills (Drug)
结局指标
主要结局
Remission
时间窗: 3 months
The main outcome measure and was defined as ultrasonographic examination being unable to detect the ovarian cyst or the cyst being less than 2 centimeters in the largest dimension.
次要结局
- Regression(3 months)
- Progression(3 months)
- Persistence(3 months)
研究者
khalid mohammed salama
assistent professor
Benha University