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L-carnitine and Metformin in Obese PCOS Women.

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT03108963
Collaborator
(none)
280
Enrollment
1
Location
2
Arms
13.9
Actual Duration (Months)
20.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: L-carnitine and Metformin
  • Drug: placebo
 Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
L-carnitine Plus Metformin in Clomiphene-resistant Obese PCOS Women, Reproductive and Metabolic Effects: a Randomized Clinical Trial
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: L-carnitine and Metformin

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

Drug: L-carnitine and Metformin
L-carnitine plus Metformin was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.
Other Names:
  • motova plus and glucphage

    		•
    Active Comparator: placebo

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

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

    Outcome Measures

    Primary Outcome Measures

    1. pregnancy rate [3 momths]

      number of women with clinical pregnancy

    Secondary Outcome Measures

    1. ovulation rate [3 momths]

      number of women with follicle >18mm.

    2. abortion rate [3 momths]

      number of women with abortions

    3. insulin resistance [3 momths]

      fasting glucose and insulin

    4. lipid metabolism [3 momths]

      Triglyceride, cholesterol

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • pco

    • obese

    • ifertile

    Exclusion Criteria:

    • no medical disorders

    • no hormonal treatment in the previous 3 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zagazig University Zagazig Egypt

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: ibrahim A el sharkwy, MD, FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IBRAHIM ABD ELGAFOR, assistant professor, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT03108963
    Other Study ID Numbers:
    • ZUH 6
    First Posted:
    Apr 11, 2017
    Last Update Posted:
    May 2, 2018
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Metformin

    Study Results

    No Results Posted as of May 2, 2018