RecruitingNot ApplicableNCT07242131

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

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


Sponsor

Ege University

Enrollment

150 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing three treatments — oral contraceptives, progesterone, and a supplement called inositol — for women with polycystic ovary syndrome (PCOS) to see which best regulates menstrual cycles and improves hormone levels. **You may be eligible if...** - You are a woman aged 18 to 40 years - You have been diagnosed with PCOS based on accepted international criteria (at least 2 of: irregular periods, excess androgens/male hormones, or polycystic ovaries on ultrasound) - You have no other significant medical conditions - You are willing to attend follow-up visits for at least 6 months **You may NOT be eligible if...** - You have liver, kidney, heart, or other endocrine disorders (other than PCOS) - You are currently pregnant or have used hormonal treatments in the past 3 months - You have a history of blood clots, breast cancer, or other contraindications to hormonal treatment - You cannot maintain regular follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCombined 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.

DIETARY_SUPPLEMENTInositol 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.

DRUGDydrogesterone 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.


Locations(1)

Izmir Bakircay University

Izmir, Menemen, Turkey (Türkiye)

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NCT07242131


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