Trial · NCT03480022
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Body Weight (BW) | 32 weeks of treatment | Treatment impact on change in body weight after 32 weeks of treatment. |
| Primary | Free Androgen Index (FAI) | 32 weeks of treatment | Drug treatment effect on free androgen levels as calculated as FAI= total testosterone (T) concentrations divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome (more androgenic). |
| Secondary | Body Mass Index (BMI) | 32 weeks of treatment | Treatment effect in reducing body mass |
| Secondary | Change in Percent Body Weight | Change from baseline (time 0) to study end (32 weeks) | Treatment effect on reducing body weight expressed as percent body weight loss from baseline |
| Secondary | 5% Weight Loss From Baseline | 32 weeks of treatment | Frequency of patients achieving 5% weight loss from baseline with treatment |
| Secondary | 10% Body Weight Loss From Baseline | 32 weeks of treatment | Frequency of patients with at least 10% reduction in body weight from baseline |
| Secondary | Abdominal Adiposity (Waist Circumference [WC] | 32 weeks of treatment | Treatment effect on loss of WC (abdominal adiposity) with drug treatment |
| Secondary | Waist-to-Hip Ratio | 32 weeks of treatment | Change in central adiposity with treatment as measured by WHR. A reduction in ratio indicates a decrease in truncal fat. |
| Secondary | Waist-to Height Ratio [WHtR]) | 32 weeks of treatment | Treatment effect on loss of central adiposity as determined by WHt ratio. The lower the ratio indicates less abdominal adiposity. |
| Secondary | Total Fat Mass Evaluated by DEXA | 32 weeks of treatment | Treatment effect on reduction of fat mass (kg) |
| Secondary | Total Body Fat (%) by DXA | 32 weeks of treatment | Treatment effect on reduction of percent body fat by DXA |
| Secondary | Android-Gynoid Ratio (AGR) by DXA | 32 weeks of treatment | Treatment impact on AGR, measure of central adiposity, as determined by DXA. A lower AGR indicates a reduction in central adiposity. |
| Secondary | Trunk/Leg Fat Ratio (TLR) by DXA | 32 weeks of treatment | Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat. |
| Secondary | Menstrual Cycle Frequency | 32 weeks of treatment | Drug treatment impact on normalization of cycle frequency (cycle every 28-30 days). All cycle data is expressed as number of menses annualized to one year. |
| Secondary | Total Testosterone Concentrations (T) | 32 weeks of treatment | Drug treatment effect on total testosterone concentrations |
| Secondary | Adrenal Dehydroepiandrosterone Sulfate (DHEAS) | 32 weeks of treatment | Treatment efficacy in reducing adrenal hyperandrogenism |
| Secondary | Fasting Blood Glucose (FG) | 32 weeks of treatment | Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT) |
| Secondary | OGTT Mean Blood Glucose (MBG) | 32 weeks of treatment | Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia. |
| Secondary | Fasting Insulin Sensitivity (HOMA-IR) | 32 weeks of treatment | Treatment effect on the HOMA-IR which is an insulin resistance measured derived from fasting blood glucose and insulin . The higher the number the more insulin resistant. |
| Secondary | Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT) | 32 weeks of treatment | The SI OGTT is a measure of peripheral insulin sensitivity derived from the insulin and glucoses measured during an OGTT. A increase in SI OGTTindicates greater insulin sensitivity |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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