Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS

Официальное название

Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)

Обзор

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.

Подробное описание

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.

A total of 150 women aged 15-40 years who meet the ESHRE/ASRM (Rotterdam) diagnostic criteria for PCOS will be enrolled at the Department of Obstetrics and Gynecology, İzmir Bakırçay University Çiğli Training and Research Hospital. Participants will be randomly assigned to one of three groups (n=50 per group):

Group 1: Oral contraceptive users

Group 2: Oral progesterone users (didrogesterone 10 mg, twice daily, cyclic regimen)

Group 3: Inositol users (2 g/day)

Clinical parameters including menstrual regularity, body mass index, hirsutism score, acne grade, and ovarian morphology (assessed via transvaginal or transabdominal ultrasonography) will be recorded at baseline and follow-up visits.

The primary outcome will be restoration of regular menstrual cycles. Secondary outcomes will include changes in ovarian morphology, reduction of hyperandrogenic symptoms, and treatment tolerability.

Data will be analyzed using appropriate parametric or non-parametric statistical tests, with significance set at p\<0.05.

All patient data will be anonymized, and participation will be voluntary following written informed consent. The study has been approved by the İzmir Bakırçay University Non-Interventional Clinical Research Ethics Committee.

Вмешательства

• Препарат Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)
  Participants 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.
• Пищевая добавка Inositol mid-level volume
  Participants 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.
• Препарат Dydrogesterone Pill
  Participants 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.

Первичные конечные точки

• Restoration of Regular Menstrual Cycles [Срок оценки: Baseline and at 6 months]

Вторичные конечные точки (3)

• Change in Ovarian Morphology [Срок оценки: Baseline and at 6 months]
• Change in Serum Hormone Levels [Срок оценки: Baseline and at 6 months]
• Patient Treatment Satisfaction [Срок оценки: After 6 months of treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Izmir Bakircay University — Izmir

Идентификаторы

NCT: NCT07242131 · Ad-PCOS-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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