Skip to content

Trial · Interventional

CompletedPhase 1Results postedRegistry data

Comparison of Two Formulations of Androxal

Overview

Status
Completed
Phase
Phase 1
Enrollment
16 participants (actual)
Sponsor
Repros Therapeutics Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
31 Dec 2013
Primary completion
31 Dec 2013
Completion
31 Dec 2013
First posted
14 Nov 2013 (estimated)
Last update posted
6 May 2019
Conditions
Bioequivalence

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014
  1. Ph 1

    Comparison of Two Formulations of Androxal

    NCT01984398

    31 Dec 2013 to 31 Dec 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • 12.5 mg Androxal Formulation ADrug
  • 12.5 mg Androxal Formulation BDrug
  • 25 mg Androxal Formulation ADrug
  • 25 mg Androxal Formulation BDrug

Arms2

  • 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

  • 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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Androxal Cmax Formulation A

    Time frame · 24 hours

    Registry description

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

  2. Androxal Cmax Formulation B

    Time frame · 24 hours

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 24 hours

Androxal Cmax Formulation A

GroupValue (ng/mL)Spread
12.5 mg Androxal Formulation A0.9990.349
25 mg Androxal Formulation A1.670.74
Primary outcomeMean· 24 hours

Androxal Cmax Formulation B

GroupValue (ng/mL)Spread
12.5 mg Androxal Formulation B1.080.42
25 mg Androxal Formulation B1.740.47

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
12.5 mg Androxal Formulation AA single dose of 12.5 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2.–0 / 82 / 8
12.5mg Androxal Formulation BA single dose of 12.5 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2.–0 / 80 / 8
25 mg Androxal Formulation AA single dose of 25 mg Androxal formulation A, received either during Treatment Period 1 or Treatment Period 2.–0 / 81 / 8
25 mg Androxal Formulation BA single dose of 25 mg Androxal formulation B, received either during Treatment Period 1 or Treatment Period 2.–0 / 81 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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: * 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.

PepBank is a research reference. Talk to a doctor before you use any peptide.