Actively Recruiting
Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS
Led by Ege University · Updated on 2025-12-18
150
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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) according to the ESHRE/ASRM (Rotterdam) criteria (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
- Availability for regular follow-up visits for at least 6 months
You will not qualify if you...
- Known hepatic, renal, cardiovascular, or endocrine disorders other than PCOS
- Pregnancy or use of hormonal therapy within the past 3 months
- History of thromboembolic disease, breast cancer, or contraindications to hormonal treatment
- Inability to adhere to follow-up visits or treatment regimen
- Severe cognitive or communication impairment preventing proper consent or data collection
- Known allergy or hypersensitivity to any study drug components
- Participation in another interventional study within the past 3 months
AI-Screening
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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
CONTACT
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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