Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Restoration of Regular Menstrual Cycles
研究概览
简要总结
This cross-sectional study aims to compare the effectiveness of oral contraceptives, oral progesterone (didrogesterone), and inositol in regulating menstrual cycles among women diagnosed with polycystic ovary syndrome (PCOS).
PCOS is a common endocrine disorder affecting reproductive-aged women and is associated with menstrual irregularities, hyperandrogenism, and polycystic ovarian morphology. While oral contraceptives are the mainstay of treatment, their use may be contraindicated in patients with cardiovascular risk factors, liver dysfunction, or in those who desire pregnancy.
This study investigates whether oral progesterone and myo-inositol can serve as effective and safer alternatives for menstrual regulation and improvement of ovarian morphology and hyperandrogenic symptoms.
A total of 150 women aged 15-40 years with a diagnosis of PCOS will be enrolled and divided into three equal groups:
Group 1: Oral contraceptive users
Group 2: Oral progesterone users
Group 3: Inositol users The study will assess changes in menstrual regularity, ovarian morphology (via ultrasound), and clinical features such as hirsutism and acne before and after treatment.
详细描述
Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age and is characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. It is one of the most prevalent causes of infertility and is frequently associated with metabolic abnormalities such as insulin resistance, obesity, and dyslipidemia.
The primary treatment goal in PCOS is to restore regular ovulatory cycles, improve ovarian morphology, and reduce hyperandrogenic symptoms such as hirsutism and acne.
Combined oral contraceptives (COCs) are the first-line pharmacological option for cycle regulation in PCOS; however, their use is contraindicated in women with risk factors such as smoking, thromboembolic disorders, severe hepatic dysfunction, uncontrolled hypertension, or a history of breast cancer. Additionally, COCs are not suitable for women who desire pregnancy in the near future.
Therefore, alternative treatments that can effectively regulate menstrual cycles without suppressing fertility or inducing metabolic risks are clinically relevant.
This study aims to compare the effects of oral contraceptives, oral progesterone, and myo-inositol on menstrual regulation and ovarian morphology in women diagnosed with PCOS.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 to 40 years.
- •Diagnosed with polycystic ovary syndrome (PCOS) according to the ESHRE/ASRM (Rotterdam) criteria (presence of at least two of the following: oligo/anovulation, clinical or biochemical hyperandrogenism, polycystic ovarian morphology).
- •No significant comorbid systemic disease.
- •Willingness to participate and ability to provide written informed consent.
- •Regular follow-up availability for at least 6 months.
排除标准
- •Known hepatic, renal, cardiovascular, or endocrine disorders other than PCOS.
- •Pregnancy or current use of hormonal therapy within the past 3 months.
- •History of thromboembolic disease, breast cancer, or other contraindications to hormonal treatment.
- •Inability to adhere to follow-up visits or treatment regimen.
- •Severe cognitive or communication impairment that prevents proper consent or data collection.
- •Known allergy or hypersensitivity to any component of the study drugs.
- •Participation in another interventional study within the past 3 months.
研究组 & 干预措施
Oral Contraceptive Group
Participants in this group will receive a combined oral contraceptive containing ethinylestradiol 0.03 mg and drospirenone 3 mg once daily for 21 days per cycle, followed by a 7-day pill-free interval, for 6 months. This arm serves as the active comparator to evaluate the relative efficacy of progesterone and myo-inositol therapy in menstrual regulation among women with PCOS.
干预措施: Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg) (Drug)
Inositol Group
Participants will receive oral inositol 2g/day for 6 months. This arm will assess the ability of myo-inositol to restore ovulatory cycles, improve ovarian morphology, and reduce hyperandrogenic symptoms in PCOS compared with oral contraceptive and progesterone groups.
干预措施: Inositol mid-level volume (Dietary Supplement)
Progesterone (Didrogesterone) Group
Participants will receive oral didrogesterone 10 mg twice daily from day 15 to day 25 of each menstrual cycle for 6 months. The efficacy of didrogesterone in restoring regular menstrual cycles and improving ovarian morphology will be compared with the oral contraceptive and myo-inositol groups.
干预措施: Dydrogesterone Pill (Drug)
结局指标
主要结局
Restoration of Regular Menstrual Cycles
时间窗: Baseline and at 6 months
Evaluation of the proportion of participants who achieve restoration of regular menstrual cycles (defined as cycle length between 25-35 days for at least three consecutive cycles) after 6 months of treatment.
次要结局
- Change in Ovarian Morphology(Baseline and at 6 months)
- Change in Serum Hormone Levels(Baseline and at 6 months)
- Patient Treatment Satisfaction(After 6 months of treatment)
研究者
Sabahattin Anıl Arı
Associate Professor
Ege University