ClinicalTrials.gg
CompletedNCT01984398Updated May 6, 2019Results posted

Comparison of Two Formulations of Androxal

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

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal

Read the detailed description

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.

02

Conditions studied

  • Bioequivalence
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Speaks, reads, and understands English or Spanish and is willing and able to provide written informed consent on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures;
  • Male, between the ages of 18-60 years;
  • No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
  • Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
  • Subject is willing to remain in the clinic overnight for the Day 1 and Day 6 visits;
  • Must be able to swallow gelatin capsules

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity to Clomid;
  • Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
  • Subject with a significant organ abnormality or disease as determined by the Investigator;
  • Any medical condition that would interfere with the study as determined by the Investigator;
  • Slow Cytochrome P4502D6 (CYP2D6) metabolizer
  • Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
  • An acute illness within 5 days of study medication administration;;
  • A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude, as determined by the Investigator;
  • History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
  • History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of (corrected QT) QTc interval prolongation;
  • An employee or family member of an employee of the study site or the Sponsor.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    12.5 mg Androxal (formulations A and B)

    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

  • Experimental
    25 mg Androxal (formulations A and 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

Interventions

06

What researchers measure

Primary outcomes

  1. Androxal Cmax Formulation A

    To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal

    Time frame: 24 hours

  2. Androxal Cmax Formulation B

    To determine and compare the PK parameter Cmax between two formulations of Androxal

    Time frame: 24 hours

07

Results

Posted May 6, 2019

Participant flow

Treatment Period 1
Participant flow — Treatment Period 1
Milestone12.5 mg Androxal (Formulation A), Then B12.5 mg Androxal (Formulation B), Then A25 mg Androxal (Formulation A), Then B25 mg Androxal (Formulation B), Then A
Started4444
Completed4444
Not completed0000
Washout Period of 5 to 7 Days
Participant flow — Washout Period of 5 to 7 Days
Milestone12.5 mg Androxal (Formulation A), Then B12.5 mg Androxal (Formulation B), Then A25 mg Androxal (Formulation A), Then B25 mg Androxal (Formulation B), Then A
Started4444
Completed4444
Not completed0000
Treatment Period 2
Participant flow — Treatment Period 2
Milestone12.5 mg Androxal (Formulation A), Then B12.5 mg Androxal (Formulation B), Then A25 mg Androxal (Formulation A), Then B25 mg Androxal (Formulation B), Then A
Started4444
Completed4444
Not completed0000

Outcome measures

PrimaryAndroxal Cmax Formulation A

To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal

Time frame:
24 hours
Reported as:
Mean · ng/mL
Androxal Cmax Formulation A
ng/mL12.5 mg Androxal Formulation A25 mg Androxal Formulation A
Androxal Cmax Formulation A0.999 ± 0.3491.67 ± 0.74
PrimaryAndroxal Cmax Formulation B

To determine and compare the PK parameter Cmax between two formulations of Androxal

Time frame:
24 hours
Reported as:
Mean · ng/mL
Androxal Cmax Formulation B
ng/mL12.5 mg Androxal Formulation B25 mg Androxal Formulation B
Androxal Cmax Formulation B1.08 ± 0.421.74 ± 0.47

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
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%)
Most frequent other events
Most frequent other events
Event12.5 mg Androxal Formulation A12.5mg Androxal Formulation B25 mg Androxal Formulation A25 mg Androxal Formulation B
HeadacheNervous system disorders2/80/81/80/8
DyspepsiaGastrointestinal disorders0/80/80/81/8

Baseline characteristics

Safety population

Age, Continuous
Age, Continuous(years)12.5 mg Androxal (Formulations A and B)25 mg Androxal (Formulations A and B)Total
Mean37.5 ± 7.537.8 ± 6.137.7 ± 6.6
Sex: Female, Male
Sex: Female, Male(Participants)12.5 mg Androxal (Formulations A and B)25 mg Androxal (Formulations A and B)Total
Female000
Male8816
Region of Enrollment
Region of Enrollment(participants)12.5 mg Androxal (Formulations A and B)25 mg Androxal (Formulations A and B)Total
United States8816
08

Study locations

1 site
  • Clinical Pharmacology of miami
    Miami, Florida 30014-3616, United States
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Nov 7, 2013
First posted
Nov 14, 2013
StartActual
Dec 31, 2013
Primary completionActual
Dec 31, 2013
CompletionActual
Dec 31, 2013
Results first posted
May 6, 2019
Last update
May 6, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01984398
Responsible party
Sponsor
First posted
Nov 14, 2013
Start date
Dec 31, 2013
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013
Results posted
May 6, 2019
Last update
May 6, 2019

Study contacts

Anna Chan
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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