Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
NCT07242131

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

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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