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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: Completed Phase 3 study, sponsored by Woman's.
NCT02635386 is a Phase 3 study that has completed, run by Woman's. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An estimation of β-cell compensatory function, the insulin secretion-sensitivity index (IS-SI) will be derived by applying the concept of the oral disposition index to measurements obtained during the 2-h OGTT and calculated as the index of insulin secretion factored by insulin sensitivity (ΔINS/ΔPG 30 x Matsuda SIOGTT) from the OGTT. A higher score shows improved pancreatic insulin responsiveness relative to resistance.
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 |
What the finished NCT02635386 record still lists
NCT02635386 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Dapagliflozin (DAPA) is the first listed.
NCT02635386 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02635386's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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