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EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)

NCT02635386 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2021-01-29

Study results available
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Summary

This is a randomized, single-blind, parallel 5 treatment group 24-week trial designed to directly compare the therapeutic effects of exenatide once weekly (EQW), dapagliflozin (DAPA), EQW plus DAPA, combined DAPA/metformin extended release (XR) and the weight loss medication, phentermine/topiramate extended release (PHEN/TPM ER) on metabolic and endocrinological parameters in overweight/obese non-diabetic women with PCOS. In this study, we will examine the efficacy of these therapies on metabolic parameters, body weight and body composition, anthropometric measurements, and reproductive function in a well-defined group of pre-menopausal overweight/obese, non-diabetic women with PCOS, focusing on their relationship to insulin resistance and obesity. We hope to determine which treatment(s) addressing the multifaceted disturbances of individual subgroups emerge as the preferable therapy.

Conditions

  • Polycystic Ovary Syndrome
  • Obesity

Interventions

DRUG

Exenatide once weekly (EQW )

2 mg SC injection every 7 days

DRUG

Dapagliflozin (DAPA)

One pill (10 mg) by mouth daily (QD) in am

DRUG

EQW plus DAPA

2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am

DRUG

Dapagliflozin plus Glucophage (MET ER)

DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose

DRUG

Phentermine /Topiramate (PHEN/ TPM) ER

PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am

Sponsors & Collaborators

Principal Investigators

  • Karen Elkind-Hirsch, PhD · Woman's Hospital, Louisiana

  • Drake Bellanger, MD · Woman's Hospital, Louisiana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-22
Primary Completion
2020-07-22
Completion
2020-10-09

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02635386 on ClinicalTrials.gov