CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 198 enrolled
Drug / intervention
Metformin +2 moredrug
Likely dose
Metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01622257
NCT01622257Phase 2Completed

Comparison of Cavitation Ultrasound, Metformin or the Combination of Both in Obese Women With Polycystic Ovary Syndrome

Ain Shams University·interventional·Posted Jun 19, 2012·Updated Apr 7, 2017

In Brief

A Phase 2 clinical trial evaluating Cavitation US, Metformin, and 1 other intervention for PCOS. Completed, enrolled 198 participants across 1 site.

Detailed Summary

The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid profile.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPCOS
CountriesEgypt
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2012
Enrollment StartJun 1, 2011
Primary CompletionJan 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.0 years ago

Interventions

Cavitation USdevice

The areas with localized fat are treated 2 times per week for 3 months using Aesthetic cavitation via ultrasonic cavitation machine (Cavi SMART, South Korea, supplied with one piece cavitation probe of 40 KHz, 3-6 watt(W)/cm\^2 adjustable, 60W with 20cm\^2 active surface).

Metformindrug

Metformin hydrochloride (Glucophage 500 mg/tablet, Bristol-Myers Squibb, New York, USA). Medication is initiated in a step-up fashion every 5 days, from one tablet per day to three. This dose is maintained as tolerated throughout the 3 months of the study.

Cavitation US + Metforminother

Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months