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Treating PCOS With Digital Intervention vs. Metformin

NCT05386706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-13

No results posted yet for this study

Summary

With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.

Conditions

  • Polycystic Ovary Syndrome

Interventions

BEHAVIORAL

Digital Intervention

This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.

DRUG

Metformin

Traditional metformin monotherapy.

Sponsors & Collaborators

  • Shanghai 10th People's Hospital

    lead OTHER

Principal Investigators

  • Shen Qu, Doctor · Shanghai 10th People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2023-08-12
Completion
2023-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05386706 on ClinicalTrials.gov