Table 2.
Mixed Model Analyses: Changes in Parameters from Day 1 to Day 28
| Placebo | 200mg | 400mg | P Values | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 11β-MNTDC (n=10) | DMAU (n=11) | 11β-MNTDC (n=15) | DMAU (n=14) | P value vs Placebo | 11β-MNTDC (n=15) | DMAU (n=13) | P value vs Placebo | P value vs 200mg | Overall Effect of Dosage Group | Effect of Androgen Type | Dosage × Drug Interaction | |
| Weight (kg) | 0.7 (−0.8, 1.5) | 0.1 (−0.9, 0.9) | 1.8 (1.2, 2.1) | 1.7 (1.1, 3.0) | 0.005** | 2.6 (1.0, 4.5) | 2.9 (1.2, 3.6) | <0.001*** | 0.06 | <0.001*** | 0.82 | 0.79 |
| Fasting Glucose (mg/dL) # | 2.0 (−1.5, 3.0) | 1.0 (−4.0, 5.0) | −1.0 (−5.0, 4.5) | −6.0 (−7.0, 2.0) | NS | 0 (−8.0, 3) | −7.0 (−10.0, −1.0) | NS | NS | 0.30 | 0.15 | 0.69 |
| Fasting Insulin (mIU/L) # | 1.2 (0.0, 4.0) | −0.1 (−1.0, 1.8) | −0.7 (−2.0, 1.9) | −1.8 (−3.1, 0.1) | NS | −1.1 (−2.7, 2.3) | −0.9 (−2.6, −0.2) | NS | NS | 0.40 | 0.15 | 0.88 |
| HOMA-IR # | 0.2 (0.1, 1.0) | −0.1 (−0.2, 0.4) | −0.0 (−0.5, 0.4) | −0.4 (−0.8, 0.07) | NS | −0.3 (−0.7, 0.6) | −0.3 (−0.5, −0.1) | NS | NS | 0.52 | 0.12 | 0.90 |
| Adiponectin (μg/mL) # | −1.5 (−1.7, −0.9) | 1.4 (−0.4, 1.9) | −0.4 (−1.9, 0.2) | −1.8 (−3.0, −1.3) | NS | −1.4 (−1.9, 0.1) | −1.3 (−3.6, 0.1) | NS | NS | 0.28 | 0.94 | 0.06 |
| HDL-C (mg/dL) | 1.0 (−5.3, 4.5) | 0.0 (−1.0, 5.5) | −11.0 (−15.0, −8.0) | −13.0 (−19.0, −8.0) | <0.001*** | −16.0 (−23.0, −10.0) | −11.0 (−15.0, −7.0) | <0.001*** | 0.96 | <0.001*** | 0.40 | 0.22 |
| LDL-C (mg/dL) | −10.5 (−20.8, −5.0) | 2.0 (−4.5, 8.5) | 11.0 (2.5, 22.0) | 4.0 (−2.0, 10.0) | 0.12 | 20.0 (13.0, 31.5) | 8.0 (0.0, 46.0) | <0.001*** | 0.09 | <0.001*** | 0.98 | 0.24 |
| Triglycerides (mg/dL) # | 7.5 (−9.8, 24.3) | −9.0 (−12.0, 9.0) | −10.0 (−17.0, −6.0) | 8.0 (−33.0, 15.0) | NS | −1.0 (−12.0, 24.0) | −6.0 (−23.0, 4.0) | NS | NS | 0.42 | 0.19 | 0.99 |
| Total Cholesterol (mg/dL) # | −10.0 (−15.0, −1.0) | −1.0 (−8.0, 23.0) | 2.0 (−9.0, 8.5) | −12.0 (−22.0, 6.0) | NS | 13.0 (−6.0, 23.5) | 2.0 (−20.0, 33.0) | NS | NS | 0.13 | 0.93 | 0.22 |
| Hematocrit (%) | −2.1 (−4.5, 0.8) | 0.0 (−1.6, 0.7) | 1.0 (0.3, 1.6) | 0.0 (−0.5, 1.8) | <0.001*** | 1.0 (−0.5, 1.5) | 2.0 (1.0, 3.0) | <0.001*** | 0.98 | <0.001*** | 0.31 | 0.28 |
| SHBG (nmol/L) | −1.0 (−6.5, 2.8) | −1.4 (−6.3, 3.7) | −21.2 (−26.9, −8.9) | −16.4 (−23.9, −14.8) | <0.001*** | −23.4 (−29.8, −11.8) | −16.8 (−24.9, −10.1) | <0.001*** | 0.93 | <0.001*** | 0.77 | 0.48 |
Median (25th, 75th percentiles). Participants missing Day 28 data were excluded from the individual analyses. Fasting insulin, HOMA-IR, and adiponectin were assessed in a subset of participants as follows: Placebo, 11β-MNTDC (n=8), DMAU (n=11); 200 mg, 11β-MNTDC (n=12), DMAU (n=14); 400 mg, 11β-MNTDC (n=11), DMAU (n=13)
*
p < 0.05;
**
p < 0.01;
***
p < 0.001;
NS = non-significant
#
Post-hoc testing to assess for differences between the individual dosage groups was only performed if the overall p value for dosage group was p < 0.05.