Clinical evaluation of Drospirenone with ethinyl estradiol and vitamin E add on therapy against polycystic ovarian syndrome- an open label pilot randomized controlled study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Drospirenone and ethinyl estradiol with vitamin E supplements may be better than drospirenone and ethinyl estradiol in relation with oxidative stress as well as hormone balance. Adolescents administered with vitamin E can have regular cycles with improvement in acne and hirsutism like symptoms.
研究概览
简要总结
According to the Rotterdam PCOS criteria, the prevalence of PCOS in India is 22.5%. At present, combined oral contraceptive (COC) is an effective method for the treatment of PCOS. The limitations of 2nd and 3rd generation COC are that they have side effects like acne and weight gain. Use of fourth-generation COC containing ethinylestradiol (EE) together with a novel progestin, drospirenone (DRSP), have claimed to have properties closer to those of natural progesterone, including anti-mineralocorticoid and anti-androgenic activities and thereby, decrease in acne formation. Vitamin E, which is critically important in the whole process of reproduction, can antagonize the oxidative stress caused by the oxygen free radicals and antioxidant imbalance and regulate normal physiological function of the reproductive system. Subjects who are diagnosed with polycystic ovarian syndrome (PCOS) according to Rotterdam criteria will be recruited. Informed consent will be obtained from all the participants. Randomization will be done in three groups by computer generated software program. Group 1 (DRSP) will be administered with 4th generation combined oral contraceptives (COC) that is drospirenone 3mg with ethinyl estradiol 20 mcg orally once daily before bedtime for 28 days: 24consecutive days with 4 days placebo tablets days (1 cycle) for period of 3 months. Group 2 (DRSP+ E2) will be administered with 4th generation combined oral contraceptives (COC) that is drosperinone 3mg with ethinyl estradiol 20 mcg orally once daily before bedtime for 28 days: 24 consecutive days with 4 days placebo tablets days (1 cycle) and vitamin E200mg once daily for the period of 3 months. Group 3 (DRSP+ E4) will be administered with 4th generation combined oral contraceptives (COC) that is drosperinone 3mg with ethinyl estradiol 20 mcg orally once daily before bedtime for 28 days: 24 consecutive days with 4 days placebo tablets days (1 cycle) and vitamin E 400mg once daily for the period of 3 months. Group 4 (Adolescent) will be administered with vitamin E 400mg once daily for the period of 3 months. All the demographic characteristics and baseline parameters will be recorded. Total testosterone, and follicle stimulating hormone (FSH) and insulin resistance will be examined in 2 months and 3 months. In Oxidative stress, Total Antioxidant Capacity (TAC) will be measured by colorimetric assay at absorbance 570nm, and Glutathione (GSH) will be measured by colorimeter at absorbance 412 nm will be measured by HPLC. All oxidative stress parameters will be determined after 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosed with polycystic ovarian syndrome according to Rotterdam criteria and did not use any injectable or implant or hormonal contraceptives within 6 months or oral contraception and IUD within 3 months before the study will be included.
排除标准
- •Women who were pregnant, want to get pregnant or suspected of being pregnant, breastfeeding women, contraindicated for using COCs, diagnosed with concomitant hyperthyroidism, Hyperprolactinemia, diabetes mellitus, renal, or adrenal insufficiency will be excluded.
结局指标
主要结局
Drospirenone and ethinyl estradiol with vitamin E supplements may be better than drospirenone and ethinyl estradiol in relation with oxidative stress as well as hormone balance. Adolescents administered with vitamin E can have regular cycles with improvement in acne and hirsutism like symptoms.
时间窗: Total testosterone, and follicle stimulating hormone (FSH) and insulin resistance by Homa- IR, Total Antioxidant Capacity (TAC), Glutathione (GSH).
次要结局
- Hirsutism and acne may be improved in adults as well as adolescents.(Acne and Hirsutism.)