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

NCT07242131 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome (PCOS)

Interventions

DRUG

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.

DIETARY_SUPPLEMENT

Inositol mid-level volume

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.

DRUG

Dydrogesterone Pill

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.

Sponsors & Collaborators

  • Ege University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07242131 on ClinicalTrials.gov