Polycystic Ovary Syndrome (PCOS)NCT07242131
Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS
A study testing Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg), Inositol mid-level volume and Dydrogesterone Pill in people with Polycystic Ovary Syndrome (PCOS), run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg), Inositol mid-level volume and Dydrogesterone Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Bakircay University
Izmir, Menemen, 35665
Sabahattin A Arı, Associate Professor, +905547139994, s.anil.ari.md@gmail.com
About this study
Official title: Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)
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.
Read more
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.
Read the detailed description
Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age and is characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. It is one of the most prevalent causes of infertility and is frequently associated with metabolic abnormalities such as insulin resistance, obesity, and dyslipidemia.
The primary treatment goal in PCOS is to restore regular ovulatory cycles, improve ovarian morphology, and reduce hyperandrogenic symptoms such as hirsutism and acne.
Combined oral contraceptives (COCs) are the first-line pharmacological option for cycle regulation in PCOS; however, their use is contraindicated in women with risk factors such as smoking, thromboembolic disorders, severe hepatic dysfunction, uncontrolled hypertension, or a history of breast cancer. Additionally, COCs are not suitable for women who desire pregnancy in the near future.
Therefore, alternative treatments that can effectively regulate menstrual cycles without suppressing fertility or inducing metabolic risks are clinically relevant.
This study aims to compare the effects of oral contraceptives, oral progesterone, and myo-inositol on menstrual regulation and ovarian morphology in women diagnosed with PCOS.
A total of 150 women aged 15-40 years who meet the ESHRE/ASRM (Rotterdam) diagnostic criteria for PCOS will be enrolled at the Department of Obstetrics and Gynecology, İzmir Bakırçay University Çiğli Training and Research Hospital. Participants will be randomly assigned to one of three groups (n=50 per group):
Group 1: Oral contraceptive users
Group 2: Oral progesterone users (didrogesterone 10 mg, twice daily, cyclic regimen)
Group 3: Inositol users (2 g/day)
Clinical parameters including menstrual regularity, body mass index, hirsutism score, acne grade, and ovarian morphology (assessed via transvaginal or transabdominal ultrasonography) will be recorded at baseline and follow-up visits.
The primary outcome will be restoration of regular menstrual cycles. Secondary outcomes will include changes in ovarian morphology, reduction of hyperandrogenic symptoms, and treatment tolerability.
Data will be analyzed using appropriate parametric or non-parametric statistical tests, with significance set at p<0.05.
All patient data will be anonymized, and participation will be voluntary following written informed consent. The study has been approved by the İzmir Bakırçay University Non-Interventional Clinical Research Ethics Committee.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg), Inositol mid-level volume, Dydrogesterone Pill
- Keywords
- Polycystic Ovary Syndrome, Menstrual Cycle, Didrogesterone
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)Drug
Participants will receive one tablet daily for 21 consecutive days, followed by a 7-day pill-free interval, for a total of 6 months. Used as the standard treatment arm for menstrual regulation in PCOS.
Inositol mid-level volumeDietary supplement
Participants will receive oral inositol 2 g/day for 6 months to assess its effects on ovulatory function, menstrual cycle regulation, and reduction of hyperandrogenic symptoms.
Dydrogesterone PillDrug
Participants will receive oral didrogesterone 10 mg twice daily from day 15 to day 25 of each menstrual cycle for 6 months (cyclic regimen).
This arm evaluates the efficacy of oral didrogesterone monotherapy in restoring regular menstruation, improving ovarian morphology, and alleviating hyperandrogenic symptoms in women with PCOS, compared with inositol and oral contraceptive.
| Study group | Role | What they receive |
|---|---|---|
| Oral Contraceptive Group | Active comparator | 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. Receives: Drug: Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg) |
| Inositol Group | Experimental | 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. Receives: Dietary Supplement: Inositol mid-level volume |
| Progesterone (Didrogesterone) Group | Experimental | 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. Receives: Drug: Dydrogesterone Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of Regular Menstrual Cycles
Evaluation of the proportion of participants who achieve restoration of regular menstrual cycles (defined as cycle length between 25-35 days for at least three consecutive cycles) after 6 months of treatment.
Measured: Baseline and at 6 months
Secondary outcomes (3)
Change in Ovarian Morphology
Assessment of changes in ovarian morphology via transvaginal or transabdominal ultrasonography, including ovarian volume and follicle count, compared with baseline.
Measured: Baseline and at 6 months
Change in Serum Hormone Levels
Comparison of baseline and post-treatment serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone, and estradiol to evaluate endocrine response to each treatment.
Measured: Baseline and at 6 months
Patient Treatment Satisfaction
Self-reported patient satisfaction and tolerability using a 5-point Likert scale evaluating ease of use, perceived effectiveness, and side effects.
Measured: After 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Dec 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Anıl Arı, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242131
- Sponsor's protocol ID
- Ad-PCOS-2
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that support the findings of this study will be made available to qualified researchers upon reasonable request. Data will include demographic information, treatment group, and primary/secondary outcome measures. Personally identifiable information will be removed to ensure participant confidentiality. Data will be available after publication of the main results and upon approval by the principal investigator and the İzmir Bakırçay University Ethics Committee. Requests for access should be directed to the corresponding author via institutional email.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT07242131
- Acronym / sponsor ID
- Ad-PCOS-2
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- Polycystic Ovary Syndrome, Menstrual Cycle, Didrogesterone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age and is characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. It is one of the most prevalent causes of infertility and is frequently associated with metabolic abnormalities such as insulin resistance, obesity, and dyslipidemia.
The primary treatment goal in PCOS is to restore regular ovulatory cycles, improve ovarian morphology, and reduce hyperandrogenic symptoms such as hirsutism and acne.
Combined oral contraceptives (COCs) are the first-line pharmacological option for cycle regulation in PCOS; however, their use is contraindicated in women with risk factors such as smoking, thromboembolic disorders, severe hepatic dysfunction, uncontrolled hypertension, or a history of breast cancer. Additionally, COCs are not suitable for women who desire pregnancy in the near future.
Therefore, alternative treatments that can effectively regulate menstrual cycles without suppressing fertility or inducing metabolic risks are clinically relevant.
This study aims to compare the effects of oral contraceptives, oral progesterone, and myo-inositol on menstrual regulation and ovarian morphology in women diagnosed with PCOS.
A total of 150 women aged 15-40 years who meet the ESHRE/ASRM (Rotterdam) diagnostic criteria for PCOS will be enrolled at the Department of Obstetrics and Gynecology, İzmir Bakırçay University Çiğli Training and Research Hospital. Participants will be randomly assigned to one of three groups (n=50 per group):
Group 1: Oral contraceptive users
Group 2: Oral progesterone users (didrogesterone 10 mg, twice daily, cyclic regimen)
Group 3: Inositol users (2 g/day)
Clinical parameters including menstrual regularity, body mass index, hirsutism score, acne grade, and ovarian morphology (assessed via transvaginal or transabdominal ultrasonography) will be recorded at baseline and follow-up visits.
The primary outcome will be restoration of regular menstrual cycles. Secondary outcomes will include changes in ovarian morphology, reduction of hyperandrogenic symptoms, and treatment tolerability.
Data will be analyzed using appropriate parametric or non-parametric statistical tests, with significance set at p<0.05.
All patient data will be anonymized, and participation will be voluntary following written informed consent. The study has been approved by the İzmir Bakırçay University Non-Interventional Clinical Research Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Contraceptive Group | Active comparator | Drug: Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)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. |
| Inositol Group | Experimental | Dietary Supplement: Inositol mid-level volumeParticipants 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. |
| Progesterone (Didrogesterone) Group | Experimental | Drug: Dydrogesterone PillParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)Participants will receive one tablet daily for 21 consecutive days, followed by a 7-day pill-free interval, for a total of 6 months. Used as the standard treatment arm for menstrual regulation in PCOS. | Drug | Oral Contraceptive Group |
| Inositol mid-level volumeParticipants will receive oral inositol 2 g/day for 6 months to assess its effects on ovulatory function, menstrual cycle regulation, and reduction of hyperandrogenic symptoms. | Dietary supplement | Inositol Group |
| Dydrogesterone PillParticipants will receive oral didrogesterone 10 mg twice daily from day 15 to day 25 of each menstrual cycle for 6 months (cyclic regimen). This arm evaluates the efficacy of oral didrogesterone monotherapy in restoring regular menstruation, improving ovarian morphology, and alleviating hyperandrogenic symptoms in women with PCOS, compared with inositol and oral contraceptive. | Drug | Progesterone (Didrogesterone) Group |
Primary outcome
Restoration of Regular Menstrual Cycles
Time frame: Baseline and at 6 months
Evaluation of the proportion of participants who achieve restoration of regular menstrual cycles (defined as cycle length between 25-35 days for at least three consecutive cycles) after 6 months of treatment.
3 secondary outcomes
Change in Ovarian Morphology
Time frame: Baseline and at 6 months
Change in Serum Hormone Levels
Time frame: Baseline and at 6 months
Patient Treatment Satisfaction
Time frame: After 6 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that support the findings of this study will be made available to qualified researchers upon reasonable request. Data will include demographic information, treatment group, and primary/secondary outcome measures. Personally identifiable information will be removed to ensure participant confidentiality. Data will be available after publication of the main results and upon approval by the principal investigator and the İzmir Bakırçay University Ethics Committee. Requests for access should be directed to the corresponding author via institutional email.
Related trials for Polycystic Ovary Syndrome (PCOS)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg), Inositol mid-level volume and Dydrogesterone Pill in people with Polycystic Ovary Syndrome (PCOS), run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabahattin A Arı, Associate Professor (+905547139994, s.anil.ari.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of Regular Menstrual Cycles (time frame: Baseline and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.