Adults 18 to 60, male only, with Bioequivalence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Androxal Cmax Formulation APrimary· 24 hours
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Group
Value
95% CI
12.5 mg Androxal Formulation A
0.999
± 0.349
25 mg Androxal Formulation A
1.67
± 0.74
Androxal Cmax Formulation BPrimary· 24 hours
To determine and compare the PK parameter Cmax between two formulations of Androxal
Group
Value
95% CI
12.5 mg Androxal Formulation B
1.08
± 0.42
25 mg Androxal Formulation B
1.74
± 0.47
Adverse events — posted to ClinicalTrials.gov
Time frame: From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT07096869 — Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Pa
· Phase 1
· recruiting
Other Repros Therapeutics Inc. trials
Trials by the same sponsor.
NCT02811159 — An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women
· Phase 2
· terminated
NCT02651688 — A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metab
· Phase 2
· completed
NCT02301897 — A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proel
· Phase 2
· completed
NCT02323646 — Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
· Phase 2
· completed
NCT01728454 — Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptom
· Phase 2
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Repros Therapeutics Inc.
Last refreshed: 6 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01984398.