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Gonadotropin DeficiencyPhase 2ITT-5NCT02147964

ITT-5 Mechanisms of Spermatogenesis in Man

A Phase 2 study testing Testosterone 1% Gel, Acyline and Dutasteride in people with Gonadotropin Deficiency, run by University of Washington at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Gonadotropin Deficiency
What is being tested?
Testosterone 1% Gel, Acyline and Dutasteride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jun 2019to Dec 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males age 18-55
  • In general good health based on normal screening evaluation
  • Normal serum testosterone, lutenizing hormone (LH) and follicle stimulating hormone (FSH)
  • Prostate Specific Antigen (PSA) < 3.0
  • Agrees not to donate blood or participate in another research study during the study
  • Informed consent
  • Must be willing to use a reliable form of contraception during the study

Who cannot join

  • Participation in a long-term male contraceptive study within the past three months
  • History of testosterone or anabolic steroid abuse in the past
  • History of or current skin disorder that will interfere with testosterone gel
  • Poor general health or significantly abnormal screening blood results
  • History of or current testicular or prostate disease
  • History of a bleeding disorder or need for anticoagulation
Show all 13Show fewer
  • History of untreated sleep apnea and/or major psychiatric problems
  • BMI > 32
  • History of or current liver disease
  • Chronic pain syndrome
  • Current use of terfenidine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil
  • Use of glucocorticoids or underlying adrenal insufficiency
  • Active drug or alcohol abuse within the past year

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington Medical Center (Health Sciences)

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Mechanisms of Hormonal Control of Spermatogenesis in Man

The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.

Read the detailed description

This is a nine-month research study examining the effects on androgen treatment on sperm production in healthy men. There are three phase to the study, a 2-month screening phase, 4-month treatment and 3-month follow-up. In this study, the investigators aim to define a quantitative relationship between intra-testicular testosterone (IT-T) and spermatogenesis in man. Hormone levels will be measured in a small amount of testicular fluid at the beginning and end of treatment and sperm concentration will be measured.

Being tested
Testosterone 1% Gel, Acyline, Dutasteride, Ketoconazole, HCG
Keywords
intratesticular androgens, testosterone, dutasteride, gonadotropin suppression, male contraception, spermatogenesis
Medical subject headings
Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testosterone 1% GelDrug

    Also called T gel, Testosterone gel, AndroGel

    Testosterone 1% gel 5g daily for 4 months [all subjects]

  • AcylineDrug

    Acyline 300 ug/kg SQ injections every 2-weeks for 4 months [all subjects]

  • DutasterideDrug

    Also called Avodart

    Dutasteride 2.5 mg (day 1) followed by 0.5 mg daily for 4 months

  • KetoconazoleDrug

    ketoconazole 400 mg PO daily for 4 months

  • HCGDrug

    Also called Human chorionic gonadotropin (HCG)

    HCG 60 IU injection Subcutaneously, every other day for 4 months

  • placebo dutasterideDrug

    placebo oral dutasteride PO daily for 4 months

  • placebo ketoconazoleDrug

    placebo ketoconazole daily for 4 months

Study groups in NCT02147964
Study groupRoleWhat they receive
Acyline; T Gel; placebo dutasteride, placebo ketoconazoleExperimentalAll men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months
Receives: Drug: Testosterone 1% Gel; Drug: Acyline; Drug: placebo dutasteride; Drug: placebo ketoconazole
Acyline; T gel; Ketoconazole; placeboExperimentalAll men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 2: oral ketoconazole 400 mg + placebo oral dutasteride for 4 months
Receives: Drug: Testosterone 1% Gel; Drug: Acyline; Drug: Ketoconazole; Drug: placebo dutasteride
Acyline; Tgel; Ketoconazole; DutasterideExperimentalAll men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 3: Ketoconazole 400mg orally daily + Dutasteride 2.5 mg orally on day 1, followed by 0.5mg daily for 4 months
Receives: Drug: Testosterone 1% Gel; Drug: Acyline; Drug: Dutasteride; Drug: Ketoconazole
Acyline; Tgel; HCGExperimentalAll men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 4: Human Chorionic gonadotropin (HCG) 60 IU injection every other day for 4 months.
Receives: Drug: Testosterone 1% Gel; Drug: Acyline; Drug: HCG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sperm concentration

    Difference in sperm concentration at week 16 between 4 treatment groups

    Measured: 16 weeks

Secondary outcomes (1)

  1. IT steroid concentration

    It steroid concentration at week 16 between the 4 treatment groups

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2014 (estimated)
  2. Study startJun 2019 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: No funding was obtained for this study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02147964
Sponsor's protocol ID
STUDY00001449
Acronym
ITT-5
Status last verified
Dec 2019
First submitted
21 May 2014
Last updated
18 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Contraceptive efficacy of testosterone-induced azoospermia in normal men. World Health Organization Task Force on methods for the regulation of male fertility. Lancet. 1990 Oct 20;336(8721):955-9.

    PubMed 1977002

  • Wu FC, Farley TM, Peregoudov A, Waites GM. Effects of testosterone enanthate in normal men: experience from a multicenter contraceptive efficacy study. World Health Organization Task Force on Methods for the Regulation of Male Fertility. Fertil Steril. 1996 Mar;65(3):626-36.

    PubMed 8774299

  • Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.

    PubMed 10386821

  • Zirkin BR, Santulli R, Awoniyi CA, Ewing LL. Maintenance of advanced spermatogenic cells in the adult rat testis: quantitative relationship to testosterone concentration within the testis. Endocrinology. 1989 Jun;124(6):3043-9. doi: 10.1210/endo-124-6-3043.

    PubMed 2498065

  • Roth MY, Lin K, Amory JK, Matsumoto AM, Anawalt BD, Snyder CN, Kalhorn TF, Bremner WJ, Page ST. Serum LH correlates highly with intratesticular steroid levels in normal men. J Androl. 2010 Mar-Apr;31(2):138-45. doi: 10.2164/jandrol.109.008391. Epub 2009 Sep 24.

    PubMed 19779211

  • Roth MY, Page ST, Lin K, Anawalt BD, Matsumoto AM, Snyder CN, Marck BT, Bremner WJ, Amory JK. Dose-dependent increase in intratesticular testosterone by very low-dose human chorionic gonadotropin in normal men with experimental gonadotropin deficiency. J Clin Endocrinol Metab. 2010 Aug;95(8):3806-13. doi: 10.1210/jc.2010-0360. Epub 2010 May 19.

    PubMed 20484472

  • Trachtenberg J, Zadra J. Steroid synthesis inhibition by ketoconazole: sites of action. Clin Invest Med. 1988 Feb;11(1):1-5.

    PubMed 2966691

  • Nashan D, Knuth UA, Weidinger G, Nieschlag E. The antimycotic drug terbinafine in contrast to ketoconazole lacks acute effects on the pituitary-testicular function of healthy men: a placebo-controlled double-blind trial. Acta Endocrinol (Copenh). 1989 May;120(5):677-81. doi: 10.1530/acta.0.1200677.

    PubMed 2499150

  • Pont A, Graybill JR, Craven PC, Galgiani JN, Dismukes WE, Reitz RE, Stevens DA. High-dose ketoconazole therapy and adrenal and testicular function in humans. Arch Intern Med. 1984 Nov;144(11):2150-3.

    PubMed 6093722

  • Van Tyle JH. Ketoconazole. Mechanism of action, spectrum of activity, pharmacokinetics, drug interactions, adverse reactions and therapeutic use. Pharmacotherapy. 1984 Nov-Dec;4(6):343-73. doi: 10.1002/j.1875-9114.1984.tb03398.x.

    PubMed 6151171

  • Roth MY, Nya-Ngatchou JJ, Lin K, Page ST, Anawalt BD, Matsumoto AM, Marck BT, Bremner WJ, Amory JK. Androgen synthesis in the gonadotropin-suppressed human testes can be markedly suppressed by ketoconazole. J Clin Endocrinol Metab. 2013 Mar;98(3):1198-206. doi: 10.1210/jc.2012-3527. Epub 2013 Jan 24.

    PubMed 23348398

  • Coviello AD, Matsumoto AM, Bremner WJ, Herbst KL, Amory JK, Anawalt BD, Sutton PR, Wright WW, Brown TR, Yan X, Zirkin BR, Jarow JP. Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression. J Clin Endocrinol Metab. 2005 May;90(5):2595-602. doi: 10.1210/jc.2004-0802. Epub 2005 Feb 15.

    PubMed 15713727

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone 1% Gel, Acyline and Dutasteride in people with Gonadotropin Deficiency, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sperm concentration (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02147964, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.

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