NCT03108963

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

April 6, 2017

Last Update Submit

May 1, 2018

Conditions

PCOS

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    number of women with clinical pregnancy

    3 momths

Secondary Outcomes (4)

  • ovulation rate

    3 momths

  • abortion rate

    3 momths

  • insulin resistance

    3 momths

  • lipid metabolism

    3 momths

Study Arms (2)

L-carnitine and Metformin

EXPERIMENTAL

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

Drug: L-carnitine and Metformin

placebo

ACTIVE COMPARATOR

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

Drug: placebo

Interventions

L-carnitine and MetforminDRUG

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

Also known as: motova plus and glucphage
L-carnitine and Metformin
placeboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pco
  • obese
  • ifertile

You may not qualify if:

  • no medical disorders
  • no hormonal treatment in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Egypt

Location

MeSH Terms

Interventions

CarnitineMetformin

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsBiguanidesGuanidinesAmidines

Study Officials

  • ibrahim A el sharkwy, MD

    FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 11, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 2, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)