Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 17 of 51 for:    "Hypogonadism" | "Estrogens"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01534208
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE February 9, 2012
First Posted Date  ICMJE February 16, 2012
Results First Submitted Date  ICMJE June 27, 2014
Results First Posted Date  ICMJE July 24, 2014
Last Update Posted Date July 24, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2014)
  • Change From Baseline in Total Morning Testosterone at 26 Weeks [ Time Frame: 6 months ]
    Changes in values from baseline of total morning testosterone levels at Week 26
  • Change From Baseline in LH [ Time Frame: 6 months ]
    Mean change from baseline in LH at end of treatment (26 weeks)
  • Absolute Values of Morning Testosterone [ Time Frame: 6 months ]
    Absolute values of morning testosterone at end of treatment (26 weeks)
  • Mean Change From Baseline FPG [ Time Frame: 6 months ]
    Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
  • Change From Baseline in BMI [ Time Frame: 6 months ]
    Mean change from baseline in BMI at end of treatment (26 weeks)
  • Change From Baseline in FSH [ Time Frame: 6 months ]
    Change from baseline in FSH at end of treatment (26 weeks)
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
  • Change in total morning testosterone from baseline to 6 months (26 weeks) [ Time Frame: 6 months ]
    Changes in values from baseline of total morning testosterone levels at Week 26 comparing Androxal to Axiron
  • Changes in follicle stimulating hormone and luteinizing hormone from baseline to 6 months (26 weeks) [ Time Frame: 6 months ]
    Changes in values from baseline in FSH and LH at each dosing visit comparing Androxal to Axiron
  • Absolute values of morning testosterone, follicle stimulating hormone, and luteinizing hormone [ Time Frame: 6 months ]
  • Changes in diabetic parameters from baseline to 6 months (26 weeks) [ Time Frame: 6 months ]
    Changes in HbA1c, fasting plasma glucose, and HOMA-IR
  • Change in subject weight from baseline to 6 months (26 weeks) [ Time Frame: 6 months ]
  • Safety Assessment at baseline versus 6 months (26 weeks) [ Time Frame: 6 months ]
    Safety will be assessed by physical and visual acuity examinations, slit lamp eye examinations, clinical laboratory tests and adverse event reporting
Change History Complete list of historical versions of study NCT01534208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Official Title  ICMJE An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Brief Summary ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.
Detailed Description This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Secondary Hypogonadism
Intervention  ICMJE Drug: Androxal
Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Other Name: Enclomiphene citrate
Study Arms  ICMJE
  • Experimental: Androxal 12.5 mg
    Androxal 12.5 mg daily
    Intervention: Drug: Androxal
  • Experimental: Androxal 25 mg
    Androxal 25 mg daily
    Intervention: Drug: Androxal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2013)
499
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2012)
550
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01534208
Other Study ID Numbers  ICMJE ZA-300
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Repros Therapeutics Inc.
Study Sponsor  ICMJE Repros Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Joseph S Podolski Repros Therapeutics Inc.
PRS Account Repros Therapeutics Inc.
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP