A Phase 1 interventional study of 12.5 mg Androxal Formulation A and 12.5 mg Androxal Formulation B in Bioequivalence, sponsored by Repros Therapeutics Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-06.
Sponsored by Repros Therapeutics Inc. (part of AbbVie) · Phase 1, Interventional, and Treatment
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers.
Repros Therapeutics Inc. is the lead sponsor of 58 studies on the registry; none are open to participants now.
First submitted before Repros Therapeutics Inc. became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
Drug: 12.5 mg Androxal Formulation A · Drug: 12.5 mg Androxal Formulation B
25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
Drug: 25 mg Androxal Formulation A · Drug: 25 mg Androxal Formulation B
Single dose of 12.5 mg Androxal formulation A
Also known as: enclomiphene citrate
Single dose of 12.5 mg Androxal Formulation B
Also known as: enclomiphene citrate
Single dose of 25 mg Androxal formulation A
Also known as: enclomiphene citrate
Single dose of 25 mg Androxal formulation B
Also known as: enclomiphene citrate
Androxal Cmax Formulation A
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Time frame: 24 hours
Androxal Cmax Formulation B
To determine and compare the PK parameter Cmax between two formulations of Androxal
Time frame: 24 hours
| Milestone | 12.5 mg Androxal (Formulation A), Then B | 12.5 mg Androxal (Formulation B), Then A | 25 mg Androxal (Formulation A), Then B | 25 mg Androxal (Formulation B), Then A |
|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | 12.5 mg Androxal (Formulation A), Then B | 12.5 mg Androxal (Formulation B), Then A | 25 mg Androxal (Formulation A), Then B | 25 mg Androxal (Formulation B), Then A |
|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | 12.5 mg Androxal (Formulation A), Then B | 12.5 mg Androxal (Formulation B), Then A | 25 mg Androxal (Formulation A), Then B | 25 mg Androxal (Formulation B), Then A |
|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 |
| Completed | 4 | 4 | 4 | 4 |
| Not completed | 0 | 0 | 0 | 0 |
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
| ng/mL | 12.5 mg Androxal Formulation A | 25 mg Androxal Formulation A |
|---|---|---|
| Androxal Cmax Formulation A | 0.999 ± 0.349 | 1.67 ± 0.74 |
To determine and compare the PK parameter Cmax between two formulations of Androxal
| ng/mL | 12.5 mg Androxal Formulation B | 25 mg Androxal Formulation B |
|---|---|---|
| Androxal Cmax Formulation B | 1.08 ± 0.42 | 1.74 ± 0.47 |
Collected over From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 12.5 mg Androxal Formulation A | — | 0/8 (0%) | 2/8 (25%) |
| 12.5mg Androxal Formulation B | — | 0/8 (0%) | 0/8 (0%) |
| 25 mg Androxal Formulation A | — | 0/8 (0%) | 1/8 (12.5%) |
| 25 mg Androxal Formulation B | — | 0/8 (0%) | 1/8 (12.5%) |
| Event | 12.5 mg Androxal Formulation A | 12.5mg Androxal Formulation B | 25 mg Androxal Formulation A | 25 mg Androxal Formulation B |
|---|---|---|---|---|
| HeadacheNervous system disorders | 2/8 | 0/8 | 1/8 | 0/8 |
| DyspepsiaGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 1/8 |
Safety population
| Age, Continuous(years) | 12.5 mg Androxal (Formulations A and B) | 25 mg Androxal (Formulations A and B) | Total |
|---|---|---|---|
| Mean | 37.5 ± 7.5 | 37.8 ± 6.1 | 37.7 ± 6.6 |
| Sex: Female, Male(Participants) | 12.5 mg Androxal (Formulations A and B) | 25 mg Androxal (Formulations A and B) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 8 | 8 | 16 |
| Region of Enrollment(participants) | 12.5 mg Androxal (Formulations A and B) | 25 mg Androxal (Formulations A and B) | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
Ran from Dec 2013 to primary completion in Dec 2013, 0 months.
Results were first posted in May 2019, 5 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Enclomiphene