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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

Overview

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

United States

Start
Jan 2011
Primary completion
Dec 2011
Completion
Dec 2011
First posted
5 Jan 2011 (estimated)
Last update posted
28 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
20112012
  1. Ph 2

    Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

    NCT01270841

    Jan 2011 to Dec 2011

Registry summary

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

The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

Interventions

  • PlaceboDrug
  • topical testosteroneDrug
  • AndroxalDrug

Arms4

  • Placebo comparator

    Placebo

    Placebo

  • Active comparator

    Testim (topical testosterone)

    Testim (topical testosterone)

  • Experimental

    Androxal 12.5 mg

    Androxal 12.5 mg/day

  • Experimental

    Androxal 25 mg

    Androxal 25 mg/day

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Total Morning Testosterone

    Time frame · 3 months

    Registry description

    Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim

Secondary outcomes(3)
  1. Change in Luteinizing Hormone Levels

    Time frame · 3 months

    Registry description

    Changes in values from baseline in LH at month 3

  2. Change in FSH After 3 Months of Treatment

    Time frame · 3 months

  3. Reproductive Safety

    Time frame · 3 months

    Registry description

    Change from baseline in sperm concentration

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· 3 months

Change in Total Morning Testosterone

GroupValue (ng/dL)Spread
Placebo-16.947.5
Testim (Topical Testosterone)253.7292.3
Androxal 12.5 mg258.5201.5
Androxal 25 mg197.3162.6
Secondary and other outcome results(3)
Secondary outcomeMean· 3 months

Change in Luteinizing Hormone Levels

GroupValue (mIU/mL)Spread
Placebo-0.11.0
Testim (Topical Testosterone)-2.42.4
Androxal 12.5 mg4.84.7
Androxal 25 mg6.97.7
Secondary outcomeMean· 3 months

Change in FSH After 3 Months of Treatment

GroupValue (mIU/mL)Spread
Placebo-0.20.7
Testim (Topical Testosterone)-4.42.9
Androxal 12.5 mg5.16.2
Androxal 25 mg7.46.5
Secondary outcomeMean· 3 months

Reproductive Safety

GroupValue (millions/mL)Spread
Placebo-19.193.4
Testim (Topical Testosterone)-29.539.0
Androxal 12.5 mg8.2233.1
Androxal 25 mg-2.8167.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboPlacebo Placebo: Placebo capsule 1x daily for 3 months–0 / 283 / 28
Testim (Topical Testosterone)Testim (topical testosterone) topical testosterone: testosterone gel applied 1x daily for 3 months–1 / 3315 / 33
Androxal 12.5 mgAndroxal 12.5 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months–0 / 273 / 27
Androxal 25 mgAndroxal 25 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months–0 / 333 / 33

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

5 results

Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone.

Wiehle et al. 2014Fertility and sterilitycited by 49

PMID 25044085DOI 10.1016/j.fertnstert.2014.06.004PUB-25044085

Full text at the publisher5 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 21 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy males between the ages of 21 and 65 years of age * All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor) * Previously or concurrently diagnosed as having secondary hypogonadism and confirmed morning testosterone \<250ng/dL (two assessments at least 10 days apart) * Ability to complete the study in compliance with the protocol * Ability to understand and provide written informed consent * Agreement to use double barrier contraception if with a fertile female partner * Agreement to provide a semen sample in the clinic Exclusion Criteria: * Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 6 months prior to study * 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 * 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 * A hematocrit \>50% 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 * Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade \> 2 based on 0-4 scale or any trace of posterior subcapsular cataract) * 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) * 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 hyperprolactinemia with or without a tumor * Chronic use of medications use such as glucocorticoids * Subjects with cystic fibrosis (mutation of the CFTR gene) * Subjects unable to provide a semen sample in the clinic * Subject has a BMI \>36 kg/m2

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