Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS

Not Applicable

Not yet recruiting

• Conditions: Polycystic Ovary Syndrome (PCOS)
• Interventions: Drug: Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg); Dietary Supplement: Inositol mid-level volume; Drug: Dydrogesterone Pill

• Registration Number: NCT07242131
• Lead Sponsor: Ege University

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.

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 Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-17
• Study First Submitted QC: 2025-11-17
• Last Update Submitted: 2025-11-17
• Study First Posted: 2025-11-21
• Last Update Posted: 2025-11-21
• Study Start: 2025-12-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Contraceptive Group	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	Inositol mid-level volume	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.
Progesterone (Didrogesterone) Group	Dydrogesterone Pill	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.

Primary Outcome Measures

Name	Time	Method
Restoration of Regular Menstrual Cycles	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.

Secondary Outcome Measures

Name	Time	Method
Change in Ovarian Morphology	Baseline and at 6 months	Assessment of changes in ovarian morphology via transvaginal or transabdominal ultrasonography, including ovarian volume and follicle count, compared with baseline.
Change in Serum Hormone Levels	Baseline and at 6 months	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.
Patient Treatment Satisfaction	After 6 months of treatment	Self-reported patient satisfaction and tolerability using a 5-point Likert scale evaluating ease of use, perceived effectiveness, and side effects.

Trial Locations

Locations (1)

Izmir Bakircay University; Izmir, Menemen, Turkey (Türkiye)