This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT02369796 |
|---|---|
| Status | Terminated |
| Phase | Phase 2 |
| Sponsor | Takeda |
| Enrollment | 15 participants |
| Design | Interventional, Non Randomized, Parallel, Masking: None |
| Conditions | Hypogonadotropic Hypogonadism |
| Interventions | TAK-448 |
| Start | Feb 2015 |
| Primary completion | Oct 2015 |
| Study completion | Nov 2015 |
| Results posted | Yes, in the registry |
| Registry last updated | Mar 31, 2017 |
Compounds on this site that cite this trial
What the registry says the trial is about
The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with hypogonadotropic hypogonadism.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups | Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose |
| Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups | Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose |
| Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups | Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose |
| Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups | Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose |
| Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Once Weekly Dosing Groups | Day 22 pre-dose |
| Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Twice Weekly Dosing Group | Day 25 pre-dose |
| Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Once Weekly Dosing Groups | Day 22 pre-dose |
| Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Twice Weekly Dosing Groups | Day 25 pre-dose |
4 secondary outcomes also registered. See the registry record for the full list.
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Nov 3, 2026. See the trial changes feed for what has changed recently.
More trials of Kisspeptin-10
- Kisspeptin-10 and Leuprolide acetate: Phase 2 Trial (NCT05896293)
- Kisspeptin-10 and GnRH: Phase 2 Trial (NCT04648969)
- Kisspeptin-10: Phase 1 Trial (NCT05633966)
- Kisspeptin-10 and GnRH: Phase 1 Trial (NCT01438073)
Research area: Sexual health and melanocortin. Every registered trial we follow is in the clinical trial tracker, and the labels used on this page are explained in our evidence standards.
