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NCT02635386 · ClinicalTrials.gov registry record · Phase 3
EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)
A Phase 3 study, sponsored by Woman's.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT02635386 is a Phase 3 study that has completed, run by Woman's. The registered enrollment target is 119 participants.
The verdict
NCT02635386, a Phase 3 study, has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study 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.
Interventions
- DRUG Dapagliflozin (DAPA)
- DRUG Exenatide once weekly (EQW )
- DRUG EQW plus DAPA
- DRUG Dapagliflozin plus Glucophage (MET ER)
- DRUG Phentermine /Topiramate (PHEN/ TPM) ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2016-03-22 |
| Est. Completion | 2020-10-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02635386
The ClinicalTrials.gov registry entry for NCT02635386 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Woman's, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Dapagliflozin (DAPA) is the first listed.
NCT02635386 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02635386 about?
NCT02635386 is a clinical study titled "EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)". 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 ...
What is the current status of trial NCT02635386?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2016-03-22. Estimated completion is 2020-10-09.
What interventions are being tested in trial NCT02635386?
The interventions under investigation include: Dapagliflozin (DAPA) (DRUG), Exenatide once weekly (EQW ) (DRUG), EQW plus DAPA (DRUG), Dapagliflozin plus Glucophage (MET ER) (DRUG), Phentermine /Topiramate (PHEN/ TPM) ER (DRUG).
Who is sponsoring clinical trial NCT02635386?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
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