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Trial · Interventional

CompletedPhase 2Registry data

Exenatide and Metformin Therapy in Overweight Women With PCOS

NCTNCT00344851 (opens ClinicalTrials.gov in a new tab)Other idRP06-010
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
60 participants (actual)
Sponsor
Metabolic Center of Louisiana Research Foundation · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2006
Primary completion
Not stated
Completion
Jun 2007
First posted
27 Jun 2006 (estimated)
Last update posted
11 Jul 2007 (estimated)
Conditions
Polycystic Ovary Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 2

    Exenatide and Metformin Therapy in Overweight Women With PCOS

    NCT00344851

    Jun 2006 to Jun 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS.

Interventions

  • metformin, exenatide or combined (metformin & exenatide )Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. - Menstrual Cyclicity ( # menses/ 24 weeks)

    Time frame · every 4 weeks

Secondary outcomes(4)

  1. BMI, WHR, FAI (T/SHBG), DHEAS, lipids,abdominal girth,

    Time frame · BMI,WHR,abdominal girth at start,12 weeks and 24 weeks, FAI, DHEAS, lipids at start and at 24 weeks

  2. insulin resistance-(HOMA and composite insulin sensitivity index [ SIOGTT),

    Time frame · at start and at 24 weeks

  3. and pancreatic ß-cell function (corrected insulin response [CIRgp] and

    Time frame · at start and at 24 weeks

  4. insulinogenic index [IGI] ).

    Time frame · at start and at 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

13 results

Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.

Elkind-Hirsch et al. 2008The Journal of clinical endocrinology and metabolismcited by 200

PMID 18460557DOI 10.1210/jc.2008-0115PUB-18460557

Full text at the publisher13 results
Publisher pageSee results (13)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:Overweight/obese women (BMI\>27) 1. Must have six or fewer menses /year or be amenorrheic 2. Have either clinical or laboratory evidence of hyperandrogenism (hirsutism or elevated testosterone (T)) and /or PCOS ovary on ultrasound Exclusion Criteria: other uncorrected endocrinopathy- hyperprolactinemia, hyper- or hypothyroidism, congenital adrenal hyperplasia or presence of overt diabetes alterations in hepatic or renal function use of hormonal medications, insulin sensitizers or medications that interfere with carbohydrate metabolism for at least 8 weeks Known active substance abuse including tobacco and alcohol. Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months \-

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