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Trial · Interventional

CompletedPhase 2Results postedRegistry data

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

Overview

Status
Completed
Phase
Phase 2
Enrollment
60 participants (actual)
Sponsor
Repros Therapeutics Inc. · Industry
Design
Randomized · Single masking
Countries
1 country

United States

Start
Jun 2011
Primary completion
Oct 2011
Completion
Oct 2011
First posted
1 Jul 2011 (estimated)
Last update posted
23 Sept 2015 (estimated)
Conditions
Secondary Hypogonadism

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012
  1. Ph 2

    The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

    NCT01386606

    Jun 2011 to Oct 2011

Registry summary

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

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.

Interventions

  • Androxal (enclomiphene citrate)Drug
  • TestosteroneDrug

Arms4

  • Experimental

    Androxal 6.25 mg

    Androxal 6.25 mg/day

  • Experimental

    Androxal 12.5 mg

    Androxal 12.5 mg/day

  • Experimental

    Androxal 25 mg

    Androxal 25 mg/day

  • Active comparator

    AndroGel

    AndroGel 5G topical testosterone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 24 Hour Average and Maximum Testosterone Concentration

    Time frame · Baseline and Week 6

    Registry description

    The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.

Secondary outcomes(2)
  1. Change in Leuteinizing Hormone (LH)

    Time frame · Baseline, Week 2, Week 4, Week 6

    Registry description

    Changes in morning LH after continuous dosing

  2. Change in Follicle Stimulating Hormone (FSH)

    Time frame · Baseline, Week 2, Week 4, Week 6

    Registry description

    Changes in morning FSH after continuous dosing

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· Baseline and Week 6

24 Hour Average and Maximum Testosterone Concentration

GroupValue (ng/dL)Spread
Androxal 6.25 mg262.380.3
Androxal 12.5 mg373.6172.1
Androxal 25 mg298.3100.5
AndroGel322.4102.9
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline, Week 2, Week 4, Week 6

Change in Leuteinizing Hormone (LH)

GroupValue (mIU/mL)Spread
Androxal 6.25 mg3.631.55
Androxal 12.5 mg4.821.63
Androxal 25 mg4.983.45
AndroGel3.572.23
Post hoc outcomeNumber· Week 6

Morning Testosterone Correlated With Serial Testosterone.

GroupValue (Number of Subjects)
Androxal Pooled Dose Levels35
Other pre specified outcomeMean· Week 6

Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.

GroupValue (ng/mL)Spread
Androxal 6.25 mg1.81540.8358
Androxal 12.5 mg3.38992.0239
Androxal 25 mg16.299312.8952
Secondary outcomeMean· Baseline, Week 2, Week 4, Week 6

Change in Follicle Stimulating Hormone (FSH)

GroupValue (mIU/mL)Spread
Androxal 6.25 mg4.611.97
Androxal 12.5 mg5.632.26
Androxal 25 mg6.314.28
AndroGel6.382.79
Other pre specified outcomeMean· Week 6

Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.

GroupValue (h)Spread
Androxal 6.25 mg2.330.98
Androxal 12.5 mg2.421.21
Androxal 25 mg2.411.48
Other pre specified outcomeMean· Week 6

Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.

GroupValue (ng*h/mL)Spread
Androxal 6.25 mg21.20014.399
Androxal 12.5 mg34.01221.419
Androxal 25 mg150.51132.32

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Androxal 6.25 mgenclomiphene citrate: capsule oral 1X a day 6 weeks–0 / 162 / 16
Androxal 12.5 mgenclomiphene citrate: capsule oral 1X a day 6 weeks–0 / 141 / 14
Androxal 25 mgenclomiphene citrate: capsule oral 1X a day 6 weeks–0 / 161 / 16
AndroGelAndroGel 5G topical testosterone Testosterone: topical gel 1X a day 6 weeks–0 / 144 / 14

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 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL. * All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor) * Ability to complete the study in compliance with the protocol * Ability to understand and provide written informed consent * Agreement to use a condom, and with a fertile female partner, another form of contraception. * Agreement to provide a semen sample in the clinic Exclusion Criteria: * Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study * Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study * Use of Clomid in the past year or during the study * Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study. * A hematocrit ≥51 % or a hemoglobin ≥17 g/dL * Clinically significant abnormal findings on screening examination * Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication * Known hypersensitivity to Clomid * Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study * Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary) * History of breast cancer * History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \>3.6 * History of known hyperprolactinemia with or without a tumor * Chronic use of medications use such as glucocorticoids * Chronic use of narcotics * Subjects known to be positive for HIV * Subjects with end stage renal disease * Subjects with cystic fibrosis (mutation of the CFTR gene) * Subjects unable to provide a semen sample in the clinic * Subject has a BMI \>42 kg/m2

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