L-carnitine and Metformin in Obese PCOS Women.

NCT ID: NCT03108963

Last Updated: 2018-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-03-31

Brief Summary

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L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and metabolic effect: a randomized clinical trial

Detailed Description

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the trial aims to compare L-carnitine and plus metformin in clomiphene-resistant obese PCOS women with placebo to state the reproductive and metabolic effects in form of pregnancy and insulin resistance parameters and lipid metabolism.

Conditions

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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L-carnitine and Metformin

L-carnitine and Metformin in Obese PCOS Women trying induction of ovulation with clomiphene citrate.

Group Type EXPERIMENTAL

L-carnitine and Metformin

Intervention Type DRUG

L-carnitine plus Metformin was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.

placebo

placebo was given toObese PCOS Women trying induction of ovulation with clomiphene citrate.

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type DRUG

placebo was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.

Interventions

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L-carnitine and Metformin

L-carnitine plus Metformin was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.

Intervention Type DRUG

placebo

placebo was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.

Intervention Type DRUG

Other Intervention Names

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motova plus and glucphage

Eligibility Criteria

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Inclusion Criteria

* pco
* obese
* ifertile

Exclusion Criteria

* no medical disorders
* no hormonal treatment in the previous 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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IBRAHIM ABD ELGAFOR

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ibrahim A el sharkwy, MD

Role: PRINCIPAL_INVESTIGATOR

FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

Locations

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Zagazig University

Zagazig, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ZUH 6

Identifier Type: -

Identifier Source: org_study_id

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