Comparing a contraceptive pill, progesterone and inositol for irregular periods in PCOS
Compares a contraceptive pill, progesterone and inositol in women with polycystic ovary syndrome.
Key facts
- Who runs it
- Ege University
- Where
- Izmir, TürkiyeSee the site
- Trial code
- Registry title
- Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 1 Dec 2025
- Planned end
- 1 Jun 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)
- Inositol mid-level volume
- Dydrogesterone Pill
- Record updated
- 18 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with polycystic ovary syndrome (PCOS) who want to regulate their menstrual cycles. It compares three treatments.
- Age
- 18 to 40 years
- Sex
- Women only
- Disease stage
- PCOS diagnosed by the ESHRE/ASRM (Rotterdam) criteria: at least two of irregular or absent ovulation, high male hormones (clinical or in blood tests), polycystic ovaries on scan. No other significant illness.
- Earlier treatment
- No hormonal therapy in the past 3 months.
Main reasons for not taking part
- Known liver, kidney, heart or hormone disorders other than PCOS
- Pregnancy
- History of blood clots, breast cancer or other reasons not to use hormonal treatment
- Allergy to any of the study drugs
- Taking part in another interventional study in the past 3 months
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Pregnancy or current use of hormonal therapy within the past 3 months
- Known hepatic, renal, cardiovascular, or endocrine disorders other than PCOS
- History of thromboembolic disease, breast cancer, or other contraindications to hormonal treatment
- Severe cognitive or communication impairment that prevents proper consent or data collection
- Known allergy or hypersensitivity to any component of the study drugs
- Inability to adhere to follow-up visits or treatment regimen
- Participation in another interventional study within the past 3 months
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Where in Türkiye
- Izmir Bakircay UniversityIzmir, TürkiyeContact: Sabahattin A Arı, Associate ProfessorTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The 3 groups in the trial
- Oral Contraceptive GroupExisting treatment, for comparison
Participants in this group will receive a combined oral contraceptive containing ethinylestradiol 0.03 mg and drospirenone 3 mg once daily for 21 days per cycle, followed by a 7-day pill-free interval, for 6 months. This arm serves as the active comparator to evaluate the relative efficacy of progesterone and myo-inositol therapy in menstrual regulation among women with PCOS.
Treatment: Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)
- Inositol GroupTreatment being tested
Participants will receive oral inositol 2g/day for 6 months. This arm will assess the ability of myo-inositol to restore ovulatory cycles, improve ovarian morphology, and reduce hyperandrogenic symptoms in PCOS compared with oral contraceptive and progesterone groups.
Treatment: Inositol mid-level volume
- Progesterone (Didrogesterone) GroupTreatment being tested
Participants will receive oral didrogesterone 10 mg twice daily from day 15 to day 25 of each menstrual cycle for 6 months. The efficacy of didrogesterone in restoring regular menstrual cycles and improving ovarian morphology will be compared with the oral contraceptive and myo-inositol groups.
Treatment: Dydrogesterone Pill
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)
- Plain-language title
- Comparing a contraceptive pill, progesterone and inositol for irregular periods in PCOSGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07242131, who can take part
- Record updated
- 18 December 2025