Comparing the pill, oral progesterone, and inositol for regulating periods in PCOS
Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Ege University Academic / other |
| Locations | 1 site (Izmir, Menemen) |
| Trial ID | NCT07242131 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Izmir, Menemen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.