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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Overview

Status
Completed
Phase
Phase 3
Enrollment
499 participants (actual)
Sponsor
Repros Therapeutics Inc. · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
May 2012
Primary completion
Oct 2013
Completion
Oct 2013
First posted
16 Feb 2012 (estimated)
Last update posted
24 Jul 2014 (estimated)
Conditions
Secondary Hypogonadism

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 3

    Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

    NCT01534208

    May 2012 to Oct 2013

Registry summary

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

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Interventions

  • AndroxalDrug

Arms2

  • Experimental

    Androxal 12.5 mg

    Androxal 12.5 mg daily

  • Experimental

    Androxal 25 mg

    Androxal 25 mg daily

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Total Morning Testosterone at 26 Weeks

    Time frame · 6 months

    Registry description

    Changes in values from baseline of total morning testosterone levels at Week 26

  2. Change From Baseline in LH

    Time frame · 6 months

    Registry description

    Mean change from baseline in LH at end of treatment (26 weeks)

  3. Absolute Values of Morning Testosterone

    Time frame · 6 months

    Registry description

    Absolute values of morning testosterone at end of treatment (26 weeks)

  4. Mean Change From Baseline FPG

    Time frame · 6 months

    Registry description

    Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)

  5. Change From Baseline in BMI

    Time frame · 6 months

    Registry description

    Mean change from baseline in BMI at end of treatment (26 weeks)

  6. Change From Baseline in FSH

    Time frame · 6 months

    Registry description

    Change from baseline in FSH at end of treatment (26 weeks)

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· 6 months

Change From Baseline in Total Morning Testosterone at 26 Weeks

GroupValue (ng/dL)Spread
Androxal 12.5 mg280.9141.4
Androxal 25 mg214.7154.7
Primary outcomeMean· 6 months

Change From Baseline in LH

GroupValue (mIu/mL)Spread
Androxal 12.5 mg4.815.69
Androxal 25 mg4.274.29
Primary outcomeMean· 6 months

Absolute Values of Morning Testosterone

GroupValue (ng/dL)Spread
Androxal 12.5 mg511.6140.8
Androxal 25 mg416.7154.7
Primary outcomeMean· 6 months

Mean Change From Baseline FPG

GroupValue (mg/dL)Spread
Androxal 12.5 mg-5.430.8
Androxal 25 mg-5.029.3
Primary outcomeMean· 6 months

Change From Baseline in BMI

GroupValue (kg/m2)Spread
Androxal 12.5 mg0.21.4
Androxal 25 mg0.31.1
Primary outcomeMean· 6 months

Change From Baseline in FSH

GroupValue (U/L)Spread
Androxal 12.5 mg5.205.19
Androxal 25 mg5.425.48

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Androxal 12.5 mgAndroxal 12.5 mg daily Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated–6 / 20766 / 207
Androxal 25 mgAndroxal 25 mg daily Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated–9 / 28392 / 283

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: 1. Secondary hypogonadal males between the ages of 18 and 65 2. Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1. 3. All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor) 4. Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone level \< 350 ng/dL for men age \< 55 and \< 300ng/dl for men age 55-65 5. LH \< 15mIU/mL (at Visit 1 only) 6. Ability to complete the study in compliance with the protocol 7. Ability to understand and provide written informed consent. Exclusion Criteria: 1. Use of an injectable pelleted testosterone within 6 months prior to study (men currently on topical testosterone products may be enrolled in the study after a 7-day washout period). 2. Use testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study 3. Use of Clomid in the past year 4. Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study. 5. A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL 6. Clinically significant abnormal findings on screening examination, based on the Investigator's assessment. 7. 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. 8. Known hypersensitivity to Clomid 9. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade \> 2 based on 0-4 scale or any trace of posterior subcapsular cataract) 10. 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 11. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary) 12. Current or history of breast cancer 13. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \> 3.6 14. Presence or history of known hyperprolactinemia with or without a tumor 15. Chronic use of medications use such as glucocorticoids 16. Chronic use of narcotics 17. Subjects know to be positive for HIV 18. End stage renal disease 19. Subjects with cystic fibrosis (mutation of the CFTR gene) 20. Enrollment in a previous Androxal study

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