BioequivalencePhase 1NCT01984398

Comparison of Two Formulations of Androxal

A Phase 1 study testing 12.5 mg Androxal Formulation A, 12.5 mg Androxal Formulation B and 25 mg Androxal Formulation A in people with Bioequivalence, run by Repros Therapeutics Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Bioequivalence
What is being tested?: 12.5 mg Androxal Formulation A, 12.5 mg Androxal Formulation B and 25 mg Androxal Formulation A
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 31 Dec 2013to 31 Dec 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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;

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of miami
Miami, Florida, 30014-3616

Other trials in United States

About this study

Official title: A Double-Blind Crossover Study In Healthy Volunteers to Compare Two Formulations of Androxal

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.

Conditions: Bioequivalence
Being tested: 12.5 mg Androxal Formulation A, 12.5 mg Androxal Formulation B, 25 mg Androxal Formulation A, 25 mg Androxal Formulation B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

12.5 mg Androxal Formulation ADrug
Also called enclomiphene citrate
Single dose of 12.5 mg Androxal formulation A
12.5 mg Androxal Formulation BDrug
Also called enclomiphene citrate
Single dose of 12.5 mg Androxal Formulation B
25 mg Androxal Formulation ADrug
Also called enclomiphene citrate
Single dose of 25 mg Androxal formulation A
25 mg Androxal Formulation BDrug
Also called enclomiphene citrate
Single dose of 25 mg Androxal formulation B

Study groups in NCT01984398
Study group	Role	What they receive
12.5 mg Androxal (formulations A and B)	Experimental	12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation Receives: Drug: 12.5 mg Androxal Formulation A; Drug: 12.5 mg Androxal Formulation B
25 mg Androxal (formulations A and B)	Experimental	25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation Receives: Drug: 25 mg Androxal Formulation A; Drug: 25 mg Androxal Formulation B

What is being measured

The primary outcome is the main question the study is designed to answer.

Androxal Cmax Formulation A
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Measured: 24 hours
Androxal Cmax Formulation B
To determine and compare the PK parameter Cmax between two formulations of Androxal
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 201331 Dec 2013

First posted14 Nov 2013 (estimated)
Study start31 Dec 2013
Primary completion31 Dec 2013
Study completion31 Dec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BioequivalenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01984398
Sponsor's protocol ID: ZA-110
Status last verified: May 2019
First submitted: 7 Nov 2013
Last updated: 6 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind Crossover Study In Healthy Volunteers to Compare Two Formulations of Androxal
ClinicalTrials.gov ID: NCT01984398
Acronym / sponsor ID: ZA-110
Conditions: Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Repros Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 31 Dec 2013 (actual)
Primary completion: 31 Dec 2013 (actual)
Study completion: 31 Dec 2013 (actual)
First posted: 14 Nov 2013 (estimated)
Results: Posted 6 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
12.5 mg Androxal (formulations A and B)	Experimental	Drug: 12.5 mg Androxal Formulation A, Drug: 12.5 mg Androxal Formulation B12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
25 mg Androxal (formulations A and B)	Experimental	Drug: 25 mg Androxal Formulation A, Drug: 25 mg Androxal Formulation B25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
12.5 mg Androxal Formulation AAlso: enclomiphene citrateSingle dose of 12.5 mg Androxal formulation A	Drug	12.5 mg Androxal (formulations A and B)
12.5 mg Androxal Formulation BAlso: enclomiphene citrateSingle dose of 12.5 mg Androxal Formulation B	Drug	12.5 mg Androxal (formulations A and B)
25 mg Androxal Formulation AAlso: enclomiphene citrateSingle dose of 25 mg Androxal formulation A	Drug	25 mg Androxal (formulations A and B)
25 mg Androxal Formulation BAlso: enclomiphene citrateSingle dose of 25 mg Androxal formulation B	Drug	25 mg Androxal (formulations A and B)

Primary outcome

Androxal Cmax Formulation A
Time frame: 24 hours
To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal
Androxal Cmax Formulation B
Time frame: 24 hours
To determine and compare the PK parameter Cmax between two formulations of Androxal

Results and safety

Results posted to the registry on 6 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
12.5 mg Androxal (Formulation A), Then B	4	4
12.5 mg Androxal (Formulation B), Then A	4	4
25 mg Androxal (Formulation A), Then B	4	4
25 mg Androxal (Formulation B), Then A	4	4

Primary outcome: Androxal Cmax Formulation A

Time frame: 24 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	12.5 mg Androxal Formulation A n = 8	25 mg Androxal Formulation A n = 8
Value	0.999 (0.349)	1.67 (0.74)

Population analysed: Safety and PK populations are the same

Primary outcome: Androxal Cmax Formulation B

Time frame: 24 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	12.5 mg Androxal Formulation B n = 8	25 mg Androxal Formulation B n = 8
Value	1.08 (0.42)	1.74 (0.47)

Population analysed: Safety and PK populations are the same

Adverse events

Time frame: From Day 0 up to Day 8. (Up to 24 hours after last dose of study drug in Treatment Period 2). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
12.5 mg Androxal Formulation A	0 of 8 (0%)	2 of 8 (25%)	Not reported
12.5mg Androxal Formulation B	0 of 8 (0%)	0 of 8 (0%)	Not reported
25 mg Androxal Formulation A	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
25 mg Androxal Formulation B	0 of 8 (0%)	1 of 8 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sponsor Corporate WebsiteLink provided by the sponsor.

Related trials for Bioequivalence

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RecruitingPhase 1
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Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Chan study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Androxal Cmax Formulation A (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01984398.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.