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CompletedNCT02169804Updated Oct 1, 2014

An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal

A Phase 1 interventional study of Androxal 25 mg in Pharmacokinetics, sponsored by Repros Therapeutics Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Repros Therapeutics Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

  • To determine and compare the pharmacokinetics (PK) of 3 doses of 25 mg Androxal in elderly healthy adult male subjects.
02

Conditions studied

  • Pharmacokinetics
03

In context

Lead sponsor

Repros Therapeutics Inc. is the lead sponsor of 57 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
  2. Male; age \<60 or ≥70 years of age
  3. No significant abnormal findings at the screening physical examination as evaluated by the Investigator;
  4. Normal laboratory values (or abnormal but not clinically significant) at screening as determined by the Investigator;
  5. Subject is willing to remain in the clinic for the screening visit and one overnight treatment visit after the 3rd dose of Androxal (approximately 36 hours for the treatment visit)
  6. Must be able to swallow gelatin capsules

Exclusion criteria

Exclusion Criteria:

  1. Known hypersensitivity to Clomid;
  2. Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Investigator;
  3. A hematocrit >54% or a hemoglobin >17 g/dL.
  4. Subject with a significant organ abnormality or disease as determined by the Investigator;
  5. Any medical condition that would interfere with the study as determined by the Investigator;
  6. Participation in a clinical trial with investigational medication within 30 days prior to study medication administration;
  7. An acute illness within 5 days of study medication administration;
  8. Positive urine drug screen at the screening visit;
  9. Known history of HIV and/or Hepatitis B or C
  10. Tobacco (nicotine products) use in the 3 months prior to the study;
  11. 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;
  12. History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary embolism);
  13. History of myocardial infarction, unstable angina, symptomatic heart failure, ventricular dysrhythmia, or known history of QTc interval prolongation;
  14. An employee or family member of an employee of the study site or the Sponsor;
  15. Previous participation in a clinical study of Androxal.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    70 years or older

    Non-smoking healthy adult males \>or equal to 70 years of age.

    Drug: Androxal 25 mg

  • Experimental
    Under 60 years of age

    Non-smoking healthy adult males\<60 years of age.

    Drug: Androxal 25 mg

Interventions

  • DrugAndroxal 25 mg
06

What researchers measure

Primary outcomes

  1. Pharmacokinetics - The Cmax will be calculated.

    Time frame: 4 days

  2. Pharmacokinetics - The Tmax will be calculated.

    Time frame: 4 days

  3. Pharmacokinetics - The AUC0-24 will be calculated.

    Time frame: 4 days

  4. Pharmacokinetics - the AUC0-∞ will be calculated.

    Time frame: 4 days

  5. Pharmacokinetics - The t½ will be calculated.

    Time frame: 4 days

Secondary outcomes

  1. Safety - Incidence of adverse events

    Time frame: 4 days

  2. Safety -Mean change from baseline in laboratory values

    Time frame: 4 days

  3. Safety - Mean change from baseline in vital signs

    Time frame: 4 days

07

Study locations

1 site
  • Miami, Florida, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02169804
Lead sponsor
Repros Therapeutics Inc.
Responsible party
Sponsor
First posted
Jun 23, 2014
Start date
Aug 2014
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Oct 1, 2014

Oversight

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

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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