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.
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.
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.
Parallel
Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)
DrugParticipants will receive one tablet daily for 21 consecutive days, followed by a 7-day pill-free interval, for a total of 6 months. Used as the standard treatment arm for menstrual regulation in PCOS.
Inositol mid-level volume
Dietary supplementParticipants will receive oral inositol 2 g/day for 6 months to assess its effects on ovulatory function, menstrual cycle regulation, and reduction of hyperandrogenic symptoms.
Dydrogesterone Pill
DrugParticipants will receive oral didrogesterone 10 mg twice daily from day 15 to day 25 of each menstrual cycle for 6 months (cyclic regimen). This arm evaluates the efficacy of oral didrogesterone monotherapy in restoring regular menstruation, improving ovarian morphology, and alleviating hyperandrogenic symptoms in women with PCOS, compared with inositol and oral contraceptive.
Restoration of Regular Menstrual Cycles
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.
Change in Ovarian Morphology
Assessment of changes in ovarian morphology via transvaginal or transabdominal ultrasonography, including ovarian volume and follicle count, compared with baseline.
Change in Serum Hormone Levels
Comparison of baseline and post-treatment serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone, and estradiol to evaluate endocrine response to each treatment.
Patient Treatment Satisfaction
Self-reported patient satisfaction and tolerability using a 5-point Likert scale evaluating ease of use, perceived effectiveness, and side effects.
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