Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS
Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)
1 other identifier
interventional
150
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 21, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
December 18, 2025
November 1, 2025
6 months
November 17, 2025
December 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and at 6 months
Secondary Outcomes (3)
Change in Ovarian Morphology
Baseline and at 6 months
Change in Serum Hormone Levels
Baseline and at 6 months
Patient Treatment Satisfaction
After 6 months of treatment
Study Arms (3)
Oral Contraceptive Group
ACTIVE COMPARATORParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
Study Sites (1)
Izmir Bakircay University
Izmir, Menemen, 35665, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 21, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
December 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- From 6 months after publication to 5 years post-publication.
- Access Criteria
- Access will be granted to researchers with methodologically sound proposals for academic and non-commercial purposes, following signing of a data access agreement.
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.