Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AndroGel · 1 trial · 1 indication
Baseline score and change in responses to Question 4 of the Psychosexual Daily Questionnaire (PDQ-Q4) from baseline to Month 12. Question 4 asks 12 questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity. The change is measured form the baseline value to Month 12.
The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters.
The number of participants whose score on the FACIT-Fatigue scale increased by at least 4 points. Scores on the FACIT- Fatigue scale range from 0 to 52, with higher scores indicating less fatigue.
Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12
Volumetric Bone Mineral Density (BMD) of spine trabecular bone as measured by QCT, mg/cm3, the calculated change in measurement from baseline to Month 12
Baseline score and change in score of the Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) test of Delayed Paragraph Recall, at baseline, Month 6 and Month 12. The WMS-R LM II involves a delayed paragraph recall activity scored in two components, each ranging from 0-25. The final score is the sum of each component, therefore falling in the range 0-50. WMS-R LM II scores were treated as continuous with change compared between treatment arms using linear random effects models adjusting for several factors: site, indicator variables of participation in each primary efficacy trial, baseline testosterone concentration (\<200), age (≤ 75), use of anti-depressants, use of PDE-inhibitors, baseline WMSR, categorical education, and version of the WMSR.
Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 g/dL from baseline. Values are No. (%) for dichotomous outcomes. Dichotomous hemoglobin response is an increase of 1 g/dL or more from baseline.
| Arm | Type | Description |
|---|---|---|
| AndroGel® (testosterone gel) | ACTIVE_COMPARATOR | The initial dose of AndroGel will be 5.0 g (containing 50 mg of testosterone) once a day. Participants will apply AndroGel once daily to the shoulders, abdomen or upper arms. The serum testosterone concentration will be measured monthly for the first three months, then at months 6, 9 and 12. If the testosterone concentration is not between 500 and 800 ng/dL at any time point, the dose will be either increased by increments of 1.25-2.5 g/day, up to a maximum of 15 g/day or decreased by increments of 1.25-3.75 ng/day. Participants will be taught how to apply the gel and they will be provided with written instructions and precautions. This information will be reviewed at each contact and visit. |
| Placebo gel | PLACEBO_COMPARATOR | Placebo gel is identical to the testosterone gel and is supplied in an identical pump bottle container. It is applied to the shoulders, abdomen or upper arms once a day. Participants will be taught how to apply the gel and they will be provided with written instructions and precautions. This information will be reviewed at each contact and visit. |
| Name | Type | Description |
|---|---|---|
| AndroGel® (testosterone gel) | DRUG | Testosterone levels will be measured at regular intervals in order to achieve a testosterone level in the desired range. |
| Placebo | DRUG | Testosterone levels will be measured at regular intervals. |
Inclusion Criteria: * Men greater than or equal to 65 years old * Total serum testosterone concentration \< 275 and \< 300 ng/dL at 7 -10 AM at each of two screening visits Exclusion Criteria: * Diagnosed prostate cancer, prostatic intraepithelial neoplasia (PIN), prostate nodule or, by the Prost...
AndroGel is a small molecule drug being developed for andropause, a condition sometimes called male menopause. It is a topical gel formulation of testosterone intended to address symptoms related to declining testosterone levels in older men. The drug is currently in Phase 3 clinical development.
AndroGel is being developed by Abbott Laboratories, which trades under the ticker symbol ABT. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of andropause in older men.
AndroGel is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed, but the drug remains under investigation for the treatment of andropause.
AndroGel has one completed Phase 3 clinical trial registered as NCT00799617, titled 'The Testosterone Trials in Older Men.' This randomized, double-blind, placebo-controlled study enrolled 790 male participants aged 65 years and older in the United States.
AndroGel is a brand name for a testosterone gel product. It is a small molecule formulation of testosterone designed for topical application. The drug is being studied for its effects on symptoms of andropause in older men.