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

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Woman's
Study ID
NCT02635386
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Exenatide once weekly (EQW ) — DRUG
    2 mg SC injection every 7 days
  • Dapagliflozin (DAPA) — DRUG
    One pill (10 mg) by mouth daily (QD) in am
  • EQW plus DAPA — DRUG
    2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
  • Dapagliflozin plus Glucophage (MET ER) — DRUG
    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
  • Phentermine /Topiramate (PHEN/ TPM) ER — DRUG
    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

Study Details

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.

Key Dates

Start date
Mar 22, 2016
Status verified
Jan 2021
Primary completion
Jul 22, 2020
Completion
Oct 9, 2020

Study Design

Enrollment
119 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exenatide once weekly (EQW )
    EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
  • Experimental: Dapagliflozin (DAPA)
    DAPA-10 mg oral pill once daily in am for 24 weeks
  • Experimental: EQW plus DAPA
    EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
  • Experimental: Dapagliflozin plus Glucophage (MET ER)
    Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
  • Active Comparator: Phentermine /Topiramate (PHEN/ TPM) ER
    Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks

Primary Outcome Measure

Oral Disposition (Insulin Sensitivity-insulin Secretion) Index [ Time Frame: 24 weeks of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Woman's HospitalBaton RougeLouisiana70817-

Find similar trials in Baton Rouge, LA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Woman's Hospital· Baton Rouge, LA

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