CClinicalTrials.gg
Sign In
CompletedNCT00706719Updated Aug 19, 2015Results posted

To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

A Phase 2 interventional study of 25 mg Androxal and Testim 1% in Secondary Hypogonadism, sponsored by Repros Therapeutics Inc.. Completed at 2 sites in United States. Open to male participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-08-19.

Sponsored by Repros Therapeutics Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
Male
01

Study summary

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.

Read the detailed description

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.

02

Conditions studied

  • Secondary Hypogonadism

Keywords

  • Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH)
  • Secondary hypogonadism
  • Semen volume
  • Sperm count
  • Sperm motility
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 17 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Repros Therapeutics Inc. is the lead sponsor of 57 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
  • Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.

Exclusion criteria

Exclusion Criteria:

  • A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
  • Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
  • Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of current prostate disease.
  • Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    25 mg Androxal no wash out

    1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period

    Drug: 25 mg Androxal

  • Active comparator
    Testim 1% (topical testosterone)

    Testim 1% Gel applied topically for 6 months

    Drug: Testim 1%

  • Experimental
    25 mg Androxal wash out

    1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone

    Drug: 25 mg Androxal

Interventions

  • Drug25 mg Androxal

    25 mg Androxal capsules, 1 capsule daily for 6 months

    Also known as: Enclomiphene citrate

  • DrugTestim 1%

    Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

    Also known as: Topical testosterone

06

What researchers measure

Primary outcomes

  1. Sperm Concentration

    Total sperm concentration was measured.

    Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)

  2. Motile Total Sperm Count

    Motile total sperm count was measured.

    Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)

  3. Semen Volume

    Semen volume was measured.

    Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)

Secondary outcomes

  1. Luteinizing Hormone (LH) Levels

    LH levels were measured.

    Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)

  2. Follicle Stimulating Hormone (FSH) Levels

    FSH levels were measured.

    Time frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)

07

Results

Posted Oct 8, 2010

Participant flow

Participant flow — Overall Study
MilestoneGroup A Testim (Topical Testosterone)Group B Androxal no WashoutGroup C Androxal With Wash Out
Started575
Completed561
Not completed014

Outcome measures

PrimarySperm Concentration

Total sperm concentration was measured.

Time frame:
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Reported as:
Mean · millions sperm/mL
Sperm Concentration
millions sperm/mLGroup A TestimGroup B Androxal no Wash Out
Baseline0.54 ± 0.7472.8 ± 92.7
Month 33.00 ± 5.20182.6 ± 115.5
Month 623.14 ± 30.67168.5 ± 92.9
Follow-Up (Month 7)21.03 ± 28.90164.0 ± 71.2
Statistical analysis
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.118
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.006
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.009
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.0024
PrimaryMotile Total Sperm Count

Motile total sperm count was measured.

Time frame:
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Reported as:
Mean · millions sperm
Motile Total Sperm Count
millions spermGroup A TestimGroup B Androxal no Wash Out
Baseline0.3 ± 0.4899.0 ± 159.6
Month 32.42 ± 5.41214.7 ± 166.0
Month 640.4 ± 55.3146.9 ± 120.0
Follow-Up (Month 7)38 ± 52.5100.3 ± 103.8
Statistical analysis
  • Group A Testim vs Group B Androxal no Wash Out · Wilcoxon (Mann-Whitney) · p = 0.15
  • Group A Testim vs Group B Androxal no Wash Out · Wilcoxon (Mann-Whitney) · p = 0.0067
  • Group A Testim vs Group B Androxal no Wash Out · Wilcoxon (Mann-Whitney) · p = 0.10
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.26
PrimarySemen Volume

Semen volume was measured.

Time frame:
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Reported as:
Mean · mL
Semen Volume
mLGroup A TestimGroup B Androxal no Wash Out
Baseline2.34 ± 1.432.23 ± 0.81
Month 32.88 ± 1.402.45 ± 1.31
Month 61.90 ± 1.032.48 ± 1.53
Follow-Up (Month 7)3.34 ± 0.832.40 ± 0.58
Statistical analysis
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.880
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.612
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.488
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.054
SecondaryLuteinizing Hormone (LH) Levels

LH levels were measured.

Time frame:
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Reported as:
Mean · mIU/mL
Luteinizing Hormone (LH) Levels
mIU/mLGroup A TestimGroup B Androxal no Wash Out
Baseline3.40 ± 2.142.92 ± 1.69
Month 30.88 ± 1.395.70 ± 3.22
Month 60.60 ± 0.586.12 ± 3.15
Follow-Up (Month 7)2.68 ± 0.482.47 ± 1.58
Statistical analysis
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.705
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.013
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.004
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.808
SecondaryFollicle Stimulating Hormone (FSH) Levels

FSH levels were measured.

Time frame:
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Reported as:
Mean · mIU/mL
Follicle Stimulating Hormone (FSH) Levels
mIU/mLGroup A TestimGroup B Androxal no Wash Out
Baseline3.38 ± 0.741.58 ± 0.74
Month 31.06 ± 1.124.53 ± 2.36
Month 60.9 ± 0.515.48 ± 2.46
Follow-Up (Month 7)3.6 ± 1.202.38 ± 0.95
Statistical analysis
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.008
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.015
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.003
  • Group A Testim vs Group B Androxal no Wash Out · t-test, 2 sided · p = 0.109

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group A Testim—0/5 (0%)0/5 (0%)
Group B Androxal no Wash Out—0/7 (0%)2/7 (28.6%)
Androxal Wash Out—0/5 (0%)4/5 (80%)
Most frequent other events
Most frequent other events
EventGroup A TestimGroup B Androxal no Wash OutAndroxal Wash Out
diarrheaGastrointestinal disorders0/50/71/5
erythemaEye disorders0/50/71/5
fatigueGeneral disorders0/50/71/5
worsening depressionPsychiatric disorders0/50/71/5
blurred visionEye disorders0/51/70/5
vasomotor flushingVascular disorders0/51/70/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group A TestimGroup B Androxal no Wash OutGroup C Androxal Wash OutTotal
<=18 years0000
Between 18 and 65 years57517
>=65 years0000
Age, Continuous
Age, Continuous(years)Group A TestimGroup B Androxal no Wash OutGroup C Androxal Wash OutTotal
Mean54.4 ± 4.8848.9 ± 8.9956.4 ± 23.852.7 ± 7.72
Sex: Female, Male
Sex: Female, Male(Participants)Group A TestimGroup B Androxal no Wash OutGroup C Androxal Wash OutTotal
Female0000
Male57517
Region of Enrollment
Region of Enrollment(participants)Group A TestimGroup B Androxal no Wash OutGroup C Androxal Wash OutTotal
United States57517
08

Study locations

2 sites
  • University Urology Associates
    New York, New York 10016, United States
  • MAZE Labs
    Purchase, New York 10577, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00706719
Lead sponsor
Repros Therapeutics Inc.
Responsible party
Sponsor
First posted
Jun 27, 2008
Start date
Jun 2008
Primary completion
Jul 2009
Completion
Aug 2009
Results posted
Oct 8, 2010
Last update
Aug 19, 2015

Study contacts

Ronald Wiehle, PhD
study director · Repros Therapeutics Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasm Metastasis→

Other studies from this sponsor

Repros Therapeutics Inc.

Start the discussion