Trial · NCT02635386
EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)
NCT02635386, Phase 3, Completed, Woman's; results first posted 2021-01-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS). Trials, record NCT02635386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02635386
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)
- NCT number
- NCT02635386
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 119 participants, actual
- Lead sponsor
- Woman's
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Interventions
- Exenatide once weekly (EQW ), Dapagliflozin (DAPA), EQW plus DAPA, Dapagliflozin plus Glucophage (MET ER), Phentermine /Topiramate (PHEN/ TPM) ER
- First posted
- 2015-12-18
- Last updated
- 2021-01-29
- Results first posted
- 2021-01-29
- Limitations and caveats
One limitation of this study is the lack of a placebo only arm. As we were interested in the effects of different treatment regimens for obese women with PCOS, this study was designed to provide all patients with drug therapy. Limitations of the present study further include the absence of gold-standard measures of insulin sensitivity ; instead we used the OGTT using established surrogate measures.. Last, serial assessments were over only 24 weeks of treatment.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Oral Disposition (Insulin Sensitivity-insulin Secretion) Index | 24 weeks of treatment | 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. |
| Secondary | Absolute Body Weight | 24 weeks of treatment | Treatment effect on body weight at 24 weeks of treatment |
| Secondary | Body Mass Index (BMI) | 24 weeks of treatment | Treatment efficacy in reducing body mass at 24 weeks of treatment |
| Secondary | Change in Percent Body Weight | Change from baseline (time 0) to study end (24 weeks) | Treatment effect on change in percent body weight from baseline |
| Secondary | Central Adiposity (Waist Circumference) | 24 weeks of treatment | Treatment effect on loss of central adiposity after 24 weeks |
| Secondary | Waist-to-Hip Ratio (WHR) | 24 weeks of treatment | Treatment impact on central adiposity after 24 weeks |
| Secondary | Waist-to-Height Ratio (WHtR) | 24 weeks of treatment | Treatment impact on WHtR which is a measure of central adiposity |
| Secondary | Total Fat Mass (kg) Evaluated by DEXA | 24 weeks of treatment | Treatment impact on total fat mass by DEXA |
| Secondary | Total Body Fat (%) by DEXA | 24 weeks of treatment | Treatment impact on percent total body fat by DEXA |
| Secondary | Android-Gynoid Ratio (AGR) as Determined by DEXA | 24 weeks of treatment | treatment impact on measure of central adiposity as determined by android/gynoid ratio |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Oral Disposition (Insulin Sensitivity-insulin Secretion) Index | 24 weeks of treatment | index score | MEAN | |
| SECONDARY | Absolute Body Weight | 24 weeks of treatment | kilogram | MEAN | |
| SECONDARY | Body Mass Index (BMI) | 24 weeks of treatment | kilogram/meter squared | MEAN | |
| SECONDARY | Change in Percent Body Weight | Change from baseline (time 0) to study end (24 weeks) | percentage change in body weight | MEAN | |
| SECONDARY | Central Adiposity (Waist Circumference) | 24 weeks of treatment | centimeters | MEAN | |
| SECONDARY | Waist-to-Hip Ratio (WHR) | 24 weeks of treatment | ratio | MEAN | |
| SECONDARY | Waist-to-Height Ratio (WHtR) | 24 weeks of treatment | ratio | MEAN | |
| SECONDARY | Total Fat Mass (kg) Evaluated by DEXA | 24 weeks of treatment | kilogram | MEAN | |
| SECONDARY | Total Body Fat (%) by DEXA | 24 weeks of treatment | percent fat mass | MEAN | |
| SECONDARY | Android-Gynoid Ratio (AGR) as Determined by DEXA | 24 weeks of treatment | ratio | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group115
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Oral Disposition (Insulin Sensitivity-insulin Secretion) Index | Exenatide Once Weekly (EQW ) | 471 | Standard Error 83 | index score | |
| Oral Disposition (Insulin Sensitivity-insulin Secretion) Index | Dapagliflozin (DAPA) | 311 | Standard Error 90 | index score | |
| Oral Disposition (Insulin Sensitivity-insulin Secretion) Index | EQW Plus DAPA | 503 | Standard Error 80 | index score | |
| Oral Disposition (Insulin Sensitivity-insulin Secretion) Index | Dapagliflozin Plus Glucophage (MET ER) | 395 | Standard Error 85 | index score | |
| Oral Disposition (Insulin Sensitivity-insulin Secretion) Index | Phentermine /Topiramate (PHEN/ TPM) ER | 545 | Standard Error 93 | index score | |
| Absolute Body Weight | Exenatide Once Weekly (EQW ) | 100.4 | Standard Error 3.7 | kilogram | |
| Absolute Body Weight | Dapagliflozin (DAPA) | 102.6 | Standard Error 4 | kilogram | |
| Absolute Body Weight | EQW Plus DAPA | 99 | Standard Error 3.7 | kilogram | |
| Absolute Body Weight | Dapagliflozin Plus Glucophage (MET ER) | 101.2 | Standard Error 3.8 | kilogram | |
| Absolute Body Weight | Phentermine /Topiramate (PHEN/ TPM) ER | 97 | Standard Error 4.1 | kilogram |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exenatide Once Weekly (EQW ) | 23 | |
| Overall Study | STARTED | Dapagliflozin (DAPA) | 23 | |
| Overall Study | STARTED | EQW Plus DAPA | 22 | |
| Overall Study | STARTED | Dapagliflozin Plus Glucophage (MET ER) | 26 | |
| Overall Study | STARTED | Phentermine /Topiramate (PHEN/ TRP) ER | 25 | |
| Overall Study | COMPLETED | Exenatide Once Weekly (EQW ) | 20 | |
| Overall Study | COMPLETED | Dapagliflozin (DAPA) | 17 | |
| Overall Study | COMPLETED | EQW Plus DAPA | 20 | |
| Overall Study | COMPLETED | Dapagliflozin Plus Glucophage (MET ER) | 19 | |
| Overall Study | COMPLETED | Phentermine /Topiramate (PHEN/ TRP) ER | 16 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events65
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Yeast infection or urinary tract infection | Renal and urinary disorders | Exenatide Once Weekly (EQW ) | 0 | 23 | |
| other | Yeast infection or urinary tract infection | Renal and urinary disorders | Dapagliflozin (DAPA) | 6 | 23 | |
| other | Yeast infection or urinary tract infection | Renal and urinary disorders | EQW Plus DAPA | 7 | 22 | |
| other | Yeast infection or urinary tract infection | Renal and urinary disorders | Dapagliflozin Plus Glucophage (MET ER) | 7 | 26 | |
| other | Yeast infection or urinary tract infection | Renal and urinary disorders | Phentermine /Topiramate (PHEN/ TPM) ER | 0 | 25 | |
| other | Nausea and upset stomach | Gastrointestinal disorders | Exenatide Once Weekly (EQW ) | 5 | 23 | |
| other | Nausea and upset stomach | Gastrointestinal disorders | Dapagliflozin (DAPA) | 0 | 23 | |
| other | Nausea and upset stomach | Gastrointestinal disorders | EQW Plus DAPA | 0 | 22 | |
| other | Nausea and upset stomach | Gastrointestinal disorders | Dapagliflozin Plus Glucophage (MET ER) | 6 | 26 | |
| other | Nausea and upset stomach | Gastrointestinal disorders | Phentermine /Topiramate (PHEN/ TPM) ER | 3 | 25 |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exenatide Once Weekly (EQW ) | 0 | 23 |
| Total, all-cause mortality | Dapagliflozin (DAPA) | 0 | 23 |
| Total, all-cause mortality | EQW Plus DAPA | 0 | 22 |
| Total, all-cause mortality | Dapagliflozin Plus Glucophage (MET ER) | 0 | 26 |
| Total, all-cause mortality | Phentermine /Topiramate (PHEN/ TPM) ER | 0 | 25 |
| Total, other adverse events | Exenatide Once Weekly (EQW ) | 10 | 23 |
| Total, other adverse events | Dapagliflozin (DAPA) | 10 | 23 |
| Total, other adverse events | EQW Plus DAPA | 13 | 22 |
| Total, other adverse events | Dapagliflozin Plus Glucophage (MET ER) | 14 | 26 |
| Total, other adverse events | Phentermine /Topiramate (PHEN/ TPM) ER | 13 | 25 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34097062 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02635386
GET https://conductscience.org/api/trials/v1/NCT02635386/registered?page=2