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

Recruiting now · Not applicable

Conditions studied: Polycystic Ovary Syndrome (PCOS)

In brief

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.

Key facts

Study ID

NCT07242131

Run by

Ege University

People needed

150

Starts

2025-12-01

Expected to finish

2026-06-01

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Izmir Bakircay University — Izmir, Menemen, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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