Comparing the pill, oral progesterone, and inositol for regulating periods in PCOS
Official title: Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)
Run by Ege University · NCT07242131 · Data updated 2026-11-12
This test will see if the combined birth-control pill, oral progesterone (dydrogesterone), or myo-inositol helps women with PCOS get regular periods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Ege University Academic / other |
| Locations | 1 site (Izmir, Menemen) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | December 18, 2025 |
| Trial ID | NCT07242131 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–40 with PCOS by Rotterdam criteria, without significant comorbid disease, who can attend follow-up for at least six months are ideal candidates.
✕Probably not a fit
Women who are pregnant, currently on recent hormonal therapy, or who have contraindications to hormonal treatments or major organ disease may not benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study will enroll 150 women aged 18–40 who meet the Rotterdam criteria for PCOS and assign them to three equal groups receiving either a combined oral contraceptive (ethinylestradiol 0.03 mg + drospirenone 3 mg), oral dydrogesterone, or myo-inositol. Participants will be followed for at least six months with outcomes including menstrual regularity, changes in ovarian morphology, and hyperandrogenic symptoms such as hirsutism and acne. The protocol excludes women with major hepatic, renal, cardiovascular, or endocrine comorbidities and those recently on hormonal therapy. Data will compare cycle restoration and side-effect profiles across the three interventions.
Why it matters
Potential benefit: If successful, the study could identify safer or fertility-preserving alternatives to combined oral contraceptives for restoring regular periods in women with PCOS.
How similar studies have gone: Combined oral contraceptives are well-established for cycle control, myo-inositol has moderate supportive evidence for improving ovulation and metabolic markers, while oral progesterone alone for cycle regulation is less well-studied, making parts of this comparison relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
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Izmir Bakircay University
Izmir, Menemen, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Sabahattin A Arı, Associate Professor
- Email: s.anil.ari.md@gmail.com
- Phone: +905547139994
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.