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Study · Randomized controlled trial · 2013

17 results

Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and Pharmacokinetics.

Wiehle R, Cunningham GR, Pitteloud N, Wike J, Hsu K, Fontenot GK, Rosner M, Dwyer A, Podolski J

BJU international12 Jul 2013Cited by 31 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study17

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, predose testosterone after six weeks of enclomiphene did not differ significantly from transdermal testosterone.

    In plain wordsIn hypogonadal men, predose testosterone did not differ significantly between enclomiphene and testosterone gel after six weeks.

    Outcome
    No significant changeDay 42 predose testosterone versus gel
    Study

    n: not reported in source

    Comparator
    Transdermal testosterone
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    25 mg daily · oral · six weeksAs given in this study (human).

    Measurements

    Mean testosterone
    604 ng/dL
    enclomiphene 25 mg daily
    SD
    160 ng/dL
    enclomiphene 25 mg daily
    Mean testosterone
    500 ng
    transdermal testosterone
    SD
    278 ng
    transdermal testosterone

    Source sentences

    Summary
    After six weeks of continuous use, the mean ± SD concentration of TT at Day 42 C0hrTT, was 604 ± 160 ng/dL for men taking the highest of dose of enclomiphene citrate (enclomiphene, 25 mg daily) and 500 ± 278 ng in those men treated with transdermal testosterone.
    2 context sentences
    Summary · context
    These values were higher than Day 1 values but not different from each other (p = 0.23, T-test).
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, all three enclomiphene doses increased predose testosterone.

    In plain wordsIn hypogonadal men, all three enclomiphene doses raised predose testosterone.

    Outcome
    IncreasePredose testosterone
    Study

    n: not reported in source

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    6.25, 12.5 and 25 mg · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    All three doses of enclomiphene increased C0hrTT, CavgTT, CmaxTT, CminTT and CrangeTT.
    2 context sentences
    Summary · context
    These values were higher than Day 1 values but not different from each other (p = 0.23, T-test).
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, all three enclomiphene doses increased average testosterone.

    In plain wordsIn hypogonadal men, all three enclomiphene doses raised average testosterone.

    Outcome
    IncreaseAverage testosterone
    Study

    n: not reported in source

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    6.25, 12.5 and 25 mg · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    All three doses of enclomiphene increased C0hrTT, CavgTT, CmaxTT, CminTT and CrangeTT.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, all three enclomiphene doses increased maximum testosterone.

    In plain wordsIn hypogonadal men, all three enclomiphene doses raised maximum testosterone.

    Outcome
    IncreaseMaximum testosterone
    Study

    n: not reported in source

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    6.25, 12.5 and 25 mg · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    All three doses of enclomiphene increased C0hrTT, CavgTT, CmaxTT, CminTT and CrangeTT.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, all three enclomiphene doses increased minimum testosterone.

    In plain wordsIn hypogonadal men, all three enclomiphene doses raised minimum testosterone.

    Outcome
    IncreaseMinimum testosterone
    Study

    n: not reported in source

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    6.25, 12.5 and 25 mg · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    All three doses of enclomiphene increased C0hrTT, CavgTT, CmaxTT, CminTT and CrangeTT.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, all three enclomiphene doses increased the testosterone concentration range.

    In plain wordsIn hypogonadal men, all three enclomiphene doses increased the testosterone concentration range.

    Outcome
    IncreaseTestosterone range
    Study

    n: not reported in source

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    6.25, 12.5 and 25 mg · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    All three doses of enclomiphene increased C0hrTT, CavgTT, CmaxTT, CminTT and CrangeTT.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, enclomiphene increased FSH, whereas transdermal testosterone had the opposite effect.

    In plain wordsIn hypogonadal men, enclomiphene raised FSH, while testosterone gel had the opposite effect.

    Outcome
    IncreaseFSH response
    Study

    n: not reported in source

    Comparator
    Transdermal testosterone
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    Dose not stated · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    Enclomiphene and transdermal testosterone increased levels of TT within two weeks, but they had opposite effects on FSH and LH
    Summary
    Enclomiphene citrate consistently increased serum TT into the normal range and increased LH and FSH above the normal range.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, enclomiphene had opposite LH effects to transdermal testosterone, which suppressed LH.

    In plain wordsIn hypogonadal men, enclomiphene had opposite LH effects to testosterone gel, which lowered LH.

    Outcome
    IncreaseLH response
    Study

    n: not reported in source

    Comparator
    Transdermal testosterone
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    Dose not stated · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    Enclomiphene and transdermal testosterone increased levels of TT within two weeks, but they had opposite effects on FSH and LH
    2 context sentences
    Summary · context
    Transdermal testosterone also raised TT, albeit with more variability, and with suppressed LH levels.
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, enclomiphene did not significantly affect TSH.

    In plain wordsIn hypogonadal men, TSH did not significantly change with enclomiphene.

    Outcome
    No significant changeTSH
    Study

    n: not reported in source

    Outcome group
    Thyroid function · Endocrine and hormones
    Studied dose
    Dose not stated · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment with enclomiphene did not significantly affect levels of TSH, ACTH, cortisol, lipids, or bone markers.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, enclomiphene did not significantly affect ACTH.

    In plain wordsIn hypogonadal men, ACTH did not significantly change with enclomiphene.

    Outcome
    No significant changeACTH
    Study

    n: not reported in source

    Outcome group
    Stress hormones · Endocrine and hormones
    Studied dose
    Dose not stated · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment with enclomiphene did not significantly affect levels of TSH, ACTH, cortisol, lipids, or bone markers.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, enclomiphene did not significantly affect cortisol.

    In plain wordsIn hypogonadal men, cortisol did not significantly change with enclomiphene.

    Outcome
    No significant changeCortisol
    Study

    n: not reported in source

    Outcome group
    Stress hormones · Endocrine and hormones
    Studied dose
    Dose not stated · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment with enclomiphene did not significantly affect levels of TSH, ACTH, cortisol, lipids, or bone markers.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  12. 12HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, enclomiphene did not significantly affect lipids.

    In plain wordsIn hypogonadal men, blood lipids did not significantly change with enclomiphene.

    Outcome
    No significant changeLipids
    Study

    n: not reported in source

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    Dose not stated · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment with enclomiphene did not significantly affect levels of TSH, ACTH, cortisol, lipids, or bone markers.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  13. 13HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, enclomiphene did not significantly affect bone markers.

    In plain wordsIn hypogonadal men, bone markers did not significantly change with enclomiphene.

    Outcome
    No significant changeBone markers
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment with enclomiphene did not significantly affect levels of TSH, ACTH, cortisol, lipids, or bone markers.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.
  14. 14HumanRandomized controlled trialEfficacy outcome

    In hypogonadal men, enclomiphene suppressed IGF-1 more than transdermal testosterone.

    In plain wordsIn hypogonadal men, enclomiphene lowered IGF-1 more than testosterone gel.

    Outcome
    DecreaseIGF-1 suppression versus gel
    Study

    n: not reported in source

    Comparator
    Transdermal testosterone
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    Dose not stated · oral · six weeksAs given in this study (human).

    Source sentences

    Summary
    Both transdermal testosterone and enclomiphene citrate decreased IGF-1 levels (p<0.05) but suppression was greater in the enclomiphene citrate groups.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.

Studies that did not test the peptide alone3

In this study, Enclomiphene was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Enclomiphene.

  1. 15HumanNot a test of Enclomiphene aloneRandomized controlled trialOther

    In hypogonadal men after six weeks of dosing, testosterone showed morning elevations, midday troughs, and rising nighttime levels.

    In plain wordsIn hypogonadal men after six weeks of dosing, testosterone rose in the morning, fell at midday, and rose at night.

    Outcome
    MixedDaily testosterone profile
    Study

    n: not reported in source

    Outcome group
    Sex hormones and fertility · Endocrine and hormones

    Source sentences

    Summary
    The patterns of TT over 24 hour period following six weeks of dosing could be fit to a non-linear function with morning elevations, mid-day troughs, and rising night-time levels.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.

    In this study, Enclomiphene was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Enclomiphene.

  2. 16HumanNot a test of Enclomiphene aloneRandomized controlled trialEfficacy outcome

    In hypogonadal men, testosterone increased within two weeks with both enclomiphene and transdermal testosterone.

    In plain wordsIn hypogonadal men, testosterone rose within two weeks with both enclomiphene and testosterone gel.

    Outcome
    IncreaseTestosterone increase within two weeks
    Study

    n: not reported in source

    Outcome group
    Sex hormones and fertility · Endocrine and hormones

    Source sentences

    Summary
    Enclomiphene and transdermal testosterone increased levels of TT within two weeks
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.

    In this study, Enclomiphene was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Enclomiphene.

  3. 17HumanNot a test of Enclomiphene aloneRandomized controlled trialEfficacy outcome

    In hypogonadal men, both enclomiphene and transdermal testosterone decreased IGF-1 levels.

    In plain wordsIn hypogonadal men, IGF-1 levels fell with both enclomiphene and testosterone gel.

    Outcome
    DecreaseIGF-1 decrease
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones

    Source sentences

    Summary
    Both transdermal testosterone and enclomiphene citrate decreased IGF-1 levels (p<0.05) but suppression was greater in the enclomiphene citrate groups.
    1 context sentence
    Summary · context
    This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus AndroGel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism.

    In this study, Enclomiphene was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Enclomiphene.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    21 Oct 2026, 15:58 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 12:50 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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