Actively Recruiting
Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol in Regulating Menstrual Cycles in Women With Polycystic Ovary Syndrome (PCOS)
Led by Ege University · Updated on 2025-12-18
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of oral contraceptives, oral progesterone (didrogesterone), and myo-inositol in regulating menstrual cycles among women diagnosed with polycystic ovary syndrome (PCOS). PCOS is a common hormonal disorder in reproductive-aged women associated with menstrual irregularities, excess male hormones, and polycystic ovaries. The study aims to compare these treatments to find alternatives to oral contraceptives, especially for women who cannot use them due to health risks or who want to preserve fertility. The study includes 150 women aged 15 to 40 years with PCOS diagnosed by accepted criteria. Participants are randomly assigned to one of three groups: oral contraceptive users taking a combined pill daily for 21 days with a 7-day break per cycle, oral progesterone (didrogesterone) users taking 10 mg twice daily from days 15 to 25 of each cycle, or inositol users taking 2 g daily. All treatments last for 6 months. The oral contraceptive group serves as the standard treatment comparison. Participants will have clinical assessments at the start and after 6 months, including menstrual regularity, ovarian ultrasound to check morphology, hormone levels, and signs of excess male hormones such as hirsutism and acne. Researchers will track how well menstrual cycles are restored and evaluate changes in ovarian appearance and hormone symptoms. Patient satisfaction and treatment tolerability will also be recorded. The study lasts 6 months with regular follow-up visits to monitor outcomes and safety.
CONDITIONS
Brief Title
Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 to 40 years
- Diagnosed with polycystic ovary syndrome (PCOS) by ESHRE/ASRM (Rotterdam) criteria
- No significant other systemic diseases
- Willing and able to provide written informed consent
- Available for regular follow-up visits for at least 6 months
You will not qualify if you...
- Known liver, kidney, cardiovascular, or endocrine diseases other than PCOS
- Pregnant or using hormonal therapy within the past 3 months
- History of thromboembolic disease, breast cancer, or contraindications to hormonal treatment
- Unable to follow treatment or attend follow-up visits
- Severe cognitive or communication impairment preventing proper consent or data collection
- Allergy or hypersensitivity to study drugs
- Participation in another interventional study within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive assigned oral treatment to regulate menstrual cycles and improve PCOS symptoms.
Regular visits throughout the 6 months for medication administration and monitoring
Trial Site Locations
Total: 1 location
1
Izmir Bakircay University
Izmir, Menemen, Turkey (Türkiye), 35665
Actively Recruiting
Research Team
S
Sabahattin A Arı, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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