A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

NCT01993225 | Completed Phase 3

• 1 other identifier: ZA-305
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

Brief Summary

This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.

Conditions

Secondary Hypogonadism

Keywords

Low Testosterone

Outcome Measures

Primary Outcomes (1)

• Comparison of the proportion of subjects who meet the composite endpoint of normal 24-hour average testosterone and sperm concentration.

  Comparison of the proportion of subjects whose 24-hour average testosterone levels are within the normal range \[300-1,040 ng/dL\] and whose sperm concentration is 15 million/mL or greater following 16 weeks of treatment with Androxal, placebo or AndroGel 1.62%.

  16 weeks of treatment

Secondary Outcomes (1)

• Proportion of subjects with mean sperm concentration less than 15 million/mL after 16 weeks of treatment comparing Androxal to placebo in a non-inferiority assessment

  16 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo Gel and Placebo capsules

Drug: Placebo Capsules; Drug: Placebo Gel

Androxal Treatment

EXPERIMENTAL

Androxal 12.5mg/25 mg and Placebo gel

Drug: Androxal 12.5 mg/25 mg; Drug: Placebo Gel

AndroGel Treatment

ACTIVE COMPARATOR

AndroGel 1.62% and Placebo Capsules

Drug: Placebo Capsules; Drug: AndroGel 1.62%

Interventions

Androxal 12.5 mg/25 mg DRUG

Androxal Treatment

Placebo Capsules DRUG

AndroGel Treatment; Placebo

AndroGel 1.62% DRUG

AndroGel Treatment

Placebo Gel DRUG

Androxal Treatment; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive
• Previously or concurrently diagnosed as having secondary hypogonadism characterized as having at least 2 consecutive morning testosterone assessments \< 300ng/dL, one of which must be confirmed at Baseline.
• LH \< 9.4 mIU/mL (at Visit 1 only)
• Sperm concentration ≥ 15 million per milliliter (assessed at V2 and Baseline). V2 and Baseline measurements must be at least 48 hours apart.
• Ability to complete the study in compliance with the protocol
• Ability to understand and provide written informed consent
• Agreement to provide a total of at least 4 semen samples in a sponsor-approved clinic on 4 separate occasions.

You may not qualify if:

• Any prior use of testosterone treatments (injectable, pelleted, transdermal or sublingual) within the last 6 months
• Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
• Use of Clomid in the past year
• Any clinically significant laboratory abnormality that does not have prior written sponsor approval. If the sponsor approves subject enrollment, this will not be considered to be a protocol deviation.
• Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study, if considered clinically stable by the investigator. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
• A hematocrit \>54
• 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
• Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade \> 2 based on 0-4 scale or any evidence of posterior subcapsular cataract)
• Abnormal fundoscopy exam such as central retinal vein occlusion
• 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
• Have received a diagnosis of irreversible infertility or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary), or history of evaluation or treatment for low fertility
• Current or history of breast cancer
• Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA\>3.6
• Presence or history of known hyperprolactinemia with or without a tumor (prolactin \> 20 ng/mL).

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (9)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Mobile, Alabama, United States

Location

Unknown Facility

Evanston, Illinois, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Garden City, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Riverton, Utah, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Enclomiphene

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clomiphene; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 25, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

US (9)