Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AndroGel® (testosterone gel)
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 testosterone gel developed by Abbott Laboratories, which trades under the ticker ABT. It is being studied in a Phase 3 clinical program for andropause, also known as age-related low testosterone in men. The product is a small molecule therapy administered as a gel.
AndroGel is being evaluated for andropause, the decline in testosterone levels that occurs in older men. The Phase 3 program enrolled men aged 65 years and older in the United States. The condition studied in the trial was andropause, and the trial included healthy volunteers.
AndroGel is developed by Abbott Laboratories, which is listed on the New York Stock Exchange under the ticker ABT. Abbott is the sponsor of the clinical program evaluating the testosterone gel in andropause.
AndroGel is in Phase 3 clinical development for andropause. The Phase 3 trial has been completed, and no active trials are currently listed. The program is investigational and has not been approved for this indication based on the available development information.
AndroGel has been studied in one Phase 3 trial, NCT00799617, titled The Testosterone Trials in Older Men. The trial was completed, enrolled 790 participants, and was randomized, double-blind, and placebo-controlled. It was conducted in the United States in men aged 65 years and older.
Yes, AndroGel is a testosterone gel, and it is also referred to as AndroGel (testosterone gel). The name AndroGel is the brand name for this specific formulation of testosterone gel developed by Abbott Laboratories.